HALO 360 User's Manual Rev F

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

INTRODUCTION ...1 INDICATED USE ...1 WARNINGS AND PRECAUTIONS...2 INSTALLATION ...5 INSTRUCTIONS FOR USE ...14 ENERGY GENERATOR SET-UP PROCEDURE...18 TROUBLESHOOTING...33 TECHNICAL SPECIFICATIONS ...39 LABELING SYMBOLS AND USER INFORMATION...45 WARRANTY INFORMATION...46 FORMS ...47

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1

INTRODUCTION The system presented in this User’s Manual consists of the HALO360 Energy Generator with HALO360 Output Cable, disposable single-use HALO360 Ablation Catheter, disposable single-use HALO360 Sizing Balloon, and an optional accessory 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 system is also included in the HALO360 Energy Generator. For the user’s convenience, the HALO360 System may be referred to in this User’s Manual as the “System”, the HALO360 Energy Generator may be referred to as the “Energy Generator”, the HALO360 Output Cable may be referred to as the “Output Cable”, the HALO360 Ablation Catheter may be referred to as the “Ablation Catheter”, the HALO360 Sizing Balloon Catheter may be referred to as the “Sizing Balloon”, and the optional HALO360 Footswitch may be referred to as the “Footswitch”. This User’s Manual provides a description of the Energy Generator, Output Cable, Ablation Catheter, Sizing Balloon, Footswitch, the Energy Generator’s controls and displays, and a sequence for its operation. This User’s Manual also supplies other information of importance to the user. This manual is intended as a User’s Manual only. Do not operate the System before thoroughly reading this manual.

2

INDICATED USE The HALO360 System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett’s Esophagus, Dieulafoy Lesions, and Angiodysplasia. EU, Canada: The HALO360 System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to Barrett’s Esophagus.

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3

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 Energy Generator be read, understood and followed before use. 3.1

WARNINGS - Energy Generator • Do not operate the energy generator before thoroughly reading this manual. • 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. • Do not remove the cover of the energy generator, as there is a potential for electrical shock. Refer to authorized personnel for service. • 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 the 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 Output Cable to ensure fluids are not aspirated into the 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 Output Cable for traces of fluid. If fluid is detected, discontinue the use of the Output Cable and order a replacement. • If the Energy Generator displays an E95 or C56 Operational Code, 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.

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• Do not deliver RF energy in areas previously treated with staples. The presence of metallic staples may 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 Energy 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. • 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: ¾

Reorient or relocate the receiving device.

¾

Increase the separation between the equipment.

¾

Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.

¾ 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. at 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 717-0003-01 (025-0140-000) Revision: F Page 3 of 50

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. • The activation tone and light are important safety features. Do not obstruct the activation light. Do not disable the audible tone. • Use only the provided Footswitch model with the Energy Generator. • The MAINS 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 Output Cable around metal objects. Wrapping cables around metal objects may induce hazardous currents.

3.5

PRECAUTIONS – Ablation Catheter • See HALO360 Ablation Catheter and HALO360 Sizing Balloon Instructions For Use

3.6

PRECAUTIONS – Sizing Balloon • See HALO360 Ablation Catheter and HALO360 Sizing Balloon Instructions For Use

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4

INSTALLATION Inspect the Energy Generator and Output Cable for any signs of physical damage to the front and/or back panel, chassis, cover, or the Output 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.

4.1

Preparing the System for Use The Energy Generator may be placed on a mounting cart or on any sturdy table or platform. It is recommended that carts have conductive wheels. Refer to hospital procedures or local codes for detailed information. Provide at least four to 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.

4.2

Mains Power Cord The Energy Generator is shipped with an approved hospital grade mains power cord. 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 sterilizable. 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. Do not spray or pour liquids directly on the unit.

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Figure 1A - HALO360 System Front View with Footswitch

1 - Energy Generator 2 - Optional Footswitch Figure 1B - HALO360 Energy Generator Rear View (Model 1100C-115B)

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Figure 1C - HALO360 Energy Generator Rear View (Model 1100C-230B)

Figure 1D - HALO360 Energy Generator front view (Models 1100C-115B & 1100C-230B)

4.4

HALO360 Energy Generator Controls A description of the control buttons and their functions are given below. Please refer to Figure 1C for location of each item on the front panel.

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4.4.1

Energy Generator Buttons Graphic

Button Description Up ▲------ Increases the value displayed in the adjacent numeric LED display. A single depression of the key increases the value by one unit. Continuous depression increments the display to the maximum allowable value. Down ▼-- Decreases the value displayed in the adjacent numeric LED display. A single depression of the key decreases the value by one unit. Continuous depression decrements the display to the minimum allowable value. RF POWER CONTROL -- Starts and stops the output of radio frequency energy. The switch is illuminated with a blue lamp when RF energy is being delivered. Initiates RF energy delivery to Ablation Catheter electrodes. Once the delivery of RF energy is completed, the balloon is automatically deflated. ONE-TOUCH BALLOON CONTROL BUTTON -Allows an inflation or deflation of the Ablation Catheter and Sizing Balloon. Pressing of the ▲ button once causes the balloon inflation system to inflate the Ablation Catheter or the Sizing Balloon to the MAXIMUM allowable pressure. Pressing of the ▼button causes the balloon inflation system to fully deflate the Ablation Catheter or Sizing Balloon.

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Graphic

Button Description RESET BUTTON -- Clears Operational Codes.

Calibrate Button – used to calibrate the Sizing Balloon Calibration is performed on the Sizing Balloon to improve measurement accuracy. The Sizing Balloon is inflated in air, prior to insertion in the patient, and the diameter is normalized to 33.7 mm.

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4.4.2 Energy Generator Displays (Green Color LEDs) Graphic

Description POWER Display -- During Catheter connected mode, displays the maximum RF power that can be applied. During RF ON mode, there is no display. Range: 1 to 350 W ENERGY DENSITY Display – Displays the maximum energy density that can be applied, as set by the Energy Generator. Energy density is calculated based on desired amount of energy divided by the area of Ablation Catheter electrode selected. Range: 10.0-12.0 J/cm2 BALLOON DIAMETER (mm) Display – Indicates diameter of organ as measured by the Sizing Balloon. Range: 1 to 99.9 mm

BALLOON PRESSURE (atm) Display – Indicates pressure level in the Automatic Inflation System. Negative pressure (i.e. a vacuum) is displayed as “LO”. Range: LO to + 9.99 ATM

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Graphic

Description SYSTEM STATUS Display – the LCD display is used to display User instructions and Operational codes and messages. The system includes a 2 x 20 character alpha-numeric display. The viewing area of this display is approximately 0.73 inches high by 3.27 inches wide and has green characters on a black background.

4.4.3 Energy Generator Indicators There are 4 colored LED’s to indicate the display and operational status of the Energy Generator. Graphic

Description SET Indicator -- A yellow LED will be illuminated when the values displayed on the Front Panel are the set values.

ARMED Indicator – a yellow LED will be illuminated when the system is in the CATHETER CONNECTED state.

COMPLETED Indicator – a green LED will be illuminated when the system has finished its energy delivery.

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Graphic

Description FAULT Indicator – a red LED will be illuminated when the system has encountered a fault.

4.4.4 Energy Generator Front Panel Receptacles and Connections Graphic

Description RF OUTPUT CABLE Connection -provides the means for delivering radio frequency energy to the Ablation Catheter and a means for determining the size/type of Catheter connected. Next to this electrical connector is the pneumatic line connection.

A description of the connections and their functions are given below. Please refer to Figure 1A and 1D for location of each item on the front and back panel.

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4.4.5 Energy Generator Rear Panel Functions Graphic

Description Equipotential Ground Stud -- Provides a means of securely linking the earth grounds of the Energy Generator to other grounded equipment.

FOOTSWITCH Receptacle -- This receptacle accepts the electrical connector leading to the footswitch. The footswitch has two foot pedals, one for controlling balloon inflation and deflation and one for controlling delivery of RF output. Both foot pedals act as a toggle, so that a single depression of the inflation foot pedal will inflate or deflate the balloon, and a single depression of the RF output foot pedal will turn the output ON if it was OFF, and vice versa. RS-232 Port -- For manufacturing and test purposes only.

Flash Memory Screw -- for manufacturing and repair access only.

| O

Power Access Module -- This module contains both the ON/OFF switch and the fuses. The voltage is selected by the orientation of the fuse drawer as marked.

Volume Control -- for adjusting the sound output volume

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5

INSTRUCTIONS FOR USE

5.1

Introduction The Energy Generator, Models 1100C-115B & 1100C-230B, is used in general surgery. The Energy Generator delivers radio frequency energy at 460 kHz in a bipolar mode to the Ablation Catheter. Since the system uses bipolar RF electrodes, no neutral electrode pad is used with this equipment. The Energy Generator measures and displays treatment Power, Energy Density, Balloon Size and Balloon Pressure. 5.1.1

HALO360 Energy Generator Inflation System The physician must use the inflation system to inflate the Ablation Catheter and the Sizing Balloon. The inflation system will provide air at 0.27 ATM and 0.51 ATM to provide a consistent inflation pressure for the balloons on the Sizing Balloon and Ablation Catheter, respectively. Note 0.27 ATM is the recommended inflation pressure for the Sizing Balloon and 0.51 ATM is the recommended inflation pressure for the Ablation Catheter. 0.27 ATM is selected as the Sizing Balloon inflation pressure because of several supporting reasons: •

A consistent pressure is desirable for physician use; there is no procedure-toprocedure variability.

•

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

•

0.27 ATM adequately inflates the Sizing Balloon.

0.51 ATM is selected as the maximum Ablation Catheter inflation pressure because of several supporting reasons: •

A consistent pressure is desirable for physician use; there is no procedure-toprocedure variability.

•

0.51 ATM is similar to pressures used on similar devices.

•

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

•

Variability in the pressure does not affect actual balloon size; sizing is accomplished by the range of Ablation Catheter sizes available.

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5.2

Accessories Accessory equipment connected to the analog and digital interfaces 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. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore, responsible that the system complies with the requirements of the system standard IEC 60601-1-1. If in doubt, consult he technical services department or your local representative. 5.2.1

HALO360 Footswitch The Footswitch allows the operator to initiate or cease the delivery of RF energy and balloon inflation and deflation without using his or her hands. This is a nonsterile device, connected to the energy generator with a 3-meter cable. The Footswitch has two operational controls (foot pedals) which will duplicate the functions of the RF ON/OFF Button and the Balloon Auto Inflation Up and Down Buttons, as follows: RF energy will be activated and deactivated using the Front Panel RF ON/OFF button, or the Footswitch. The Footswitch operates as Press to Engage, Release and Press to Disengage. 5.2.1.1

One foot pedal is labeled “Auto Inflation” and functions as a toggle switch that alternatively operates as the Auto Inflation Up and Auto Inflation Down Buttons. The color of this foot pedal is gray. •

A single depression of this pedal will automatically inflate the balloon to the preset inflation pressure depending on Catheter type. ¾ If a Sizing Balloon is connected, the Energy Generator will inflate the balloon to the Sizing Balloon inflation pressure. ¾ If an Ablation Catheter is connected, the Energy Generator will inflate the balloon to the Ablation Catheter inflation pressure.

• 5.2.1.2

A successive depression of this pedal will automatically deflate the balloon to a minimum of -0.136 ATM (-2.0 PSI).

One foot pedal is labeled “RF ON/OFF” and initiates delivery of RF energy in the same manner as the RF ON/OFF Button on the Energy Generator Front Panel. The color of this foot pedal is blue. •

If RF energy delivery has been enabled by inflating the balloon to the pressure required to enable RF delivery, a single depression of the RF ON/OFF Foot Pedal initiates delivery of RF energy. RF energy is continued regardless of the state of the foot pedal (i.e. whether the user maintains the foot pedal depressed, or releases the foot pedal).

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•

If RF energy is active and the user releases, then depresses the foot pedal, RF energy delivery ceases. The last electrode that energy was delivered through and the final energy density delivered is be displayed on the Energy Generator Front Panel. CAUTION: Do not continually depress the footswitch during the procedure.

5.2.1.3

5.2.2

Footswitch Cleaning Instructions: Use a mild detergent and damp cloth, followed by a disinfectant to clean the footswitch and guard. The Footswitch is not sterilizable.

HALO360 Output Cable The Output Cable is a reusable cable that connects the Energy Generator to the Sizing balloon and the Ablation Catheter. The Output Cable contains both the electrical and pneumatic conductors required to interface HALO360 Catheters to the HALO360 Energy Generator. It allows the Energy Generator to control inflation and deflation of the balloon on HALO360 Catheters, and also deliver power to the three (3) electrodes on the HALO360 Ablation Catheter. The Output Cable is approximately 9’ in length and 3/4” in diameter. The Output Cable terminates into both a male Luer pneumatic fitting and a 10 pin electrical connector (4 for RF and 6 for electrical signals) at the Catheter end of the Output Cable, and both a “quick connect” pneumatic connector and 24 pin electrical connector (7 for RF and 17 for electrical signals) at the Energy Generator end of the Output Cable. The Output Cable incorporates a “clamp” that allows it to be fixed to a patient’s bed sheets to support the weight of approximately 3’ of the Output Cable. The position of the clamp is adjustable along the segment of the Output Cable that is from 6” to 18” from the Catheter end of the Output Cable.

5.2.3

HALO360Ablation Catheter The Ablation Catheter incorporates an inflatable balloon that distends to a preset diameter. It contains three contiguous electrode circuits that completely encircle the balloon. The balloon is provided in a range of sizes to accommodate esophageal diameters ranging from 22 mm to 34 mm, in 3 mm increments. The electrodes on the Ablation Catheter are designed to create superficial lesions in tissue and deliver 300 W of power at up to 12 J/cm2 of energy density per circuit. By virtue of the combination of power, energy density and electrode design, the system creates a uniform ablation zone that is contiguous across the electrode area in contact with tissue.

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Models are as follows: Model # Description – nominal length in all cases is 87 cm 31041-22 22mm HALO360 Ablation Catheter

22mm

31041-25

25mm HALO360 Ablation Catheter

25mm

31041-28

28mm HALO360 Ablation Catheter

28mm

360

31041-31

31mm HALO

Ablation Catheter

31mm

31041-34

34mm HALO360 Ablation Catheter

34mm

HALO360 Sizing Balloon A Sizing Balloon (whose length is the same as the ablation catheter) is used for confirmation of esophagus diameter. This allows the user to confirm the diameter of the esophagus without having to use the HALO360 Ablation Catheter. See HALO360 Ablation Catheter and HALO360 Sizing Balloon Instructions For Use CAUTION: REMOVE COVER FROM THE BALLOON BEFORE CATHETER INSERTION

BALLOON

25 60

Guidewire Lumen

20

SHAFT

SOFT TIP

65

•

4

5.3

Balloon Diameter

DISTAL END ELECTRICAL CONNECTOR

Guidewire Lumen

PNEUMATIC CONNECTOR

PROXIMAL END

Figure 2 –Sizing Balloon

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6

ENERGY GENERATOR SET-UP PROCEDURE

6.1

Connection of Accessories 6.1.1

Ablation Catheter Connections The Ablation Catheter’s pneumatic and electrical connectors are directly connected to the Energy Generator using the Output Cable that is supplied with the Energy Generator. Insert the pneumatic and electrical Ablation Catheter connectors into the connections on the Output Cable. 1

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 Output Cable to ensure fluids are not aspirated into the Output Cable in the event of a Catheter leak. Failure to attach the filter may result in the fluid contamination of the Output Cable and mandatory Output Cable replacement. Attach the Ablation Catheter connection only when the Energy Generator is powered OFF or is in the STANDBY mode. 6.1.2

Footswitch Connection (optional) Connect the provided Footswitch by inserting its electrical connector into the socket directly under the label “FOOTSWITCH” on the rear panel of the Energy Generator.

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.

1 Osmonics, Inc. - Cameo 17GF Syringe Filter, 45 micron, 17 mm, #DGF04T175X Phone: 1-800-444-8212 717-0003-01 (025-0140-000) Revision: F Page 18 of 50