HALO Flex Users Manual Rev D

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

INTRODUCTION ...1 INDICATED USE ...1 CONTRAINDICATIONS ...2 WARNINGS AND PRECAUTIONS ...2 INSTALLATION ...4 ENERGY GENERATOR AND ACCESSORIES ...12 SET-UP PROCEDURE AND INSTRUCTIONS FOR USE ...15 TROUBLESHOOTING...26 TECHNICAL SPECIFICATIONS ...35 LABELING SYMBOLS AND USER INFORMATION ...40 WARRANTY INFORMATION ...41 FORMS ...42

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1

INTRODUCTION The System presented in this User’s Manual consists of the HALOFLEX Energy Generator with HALOFLEX Output Cable, disposable single-use HALO360+ Ablation Catheter or HALO90 Ablation Catheter, disposable single-use HALO360 Sizing Balloon or HALO360+ Sizing Balloon and an optional accessory HALOFLEX Footswitch. The HALOFLEX Energy Generator supplies up to 300 watts of radiofrequency (RF) 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 and the HALO90 Ablation Catheter. An inflation system is also included in the HALOFLEX Energy Generator. For the user’s convenience, the HALOFLEX System may be referred to in this User’s Manual as the “System,” the HALOFLEX Energy Generator may be referred to as the “Energy Generator,” the HALOFLEX Output Cable may be referred to as the “Output Cable,” the HALO360+ Ablation Catheters may be referred to as “Balloon Based Ablation Catheters,” the HALO90 Ablation Catheter may be referred to as “Non Balloon Based Ablation Catheter,” the HALO360+ Ablation Catheter and HALO90 Ablation Catheters may be referred to jointly as “Ablation Catheter,” the HALO360 Sizing Balloon or HALO360+ Sizing Balloon may be referred to as the “Sizing Balloon,” the Ablation Catheters and Sizing Balloons may be referred to jointly as “Catheters” or “Disposable Devices” and the optional HALOFLEX Footswitch may be referred to as the “Footswitch.” The Footswitch Unit houses 2 Foot Pedals, RF POWER ON/OFF – blue pedal and AUTO INFLATION – gray pedal, and may be referred to as “Foot Pedal.” This User’s Manual provides a description of the Energy Generator, Output Cable, Disposable Devices, 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 or reading the IFU for the specific Ablation Catheter or Sizing Balloon being used.

2

INDICATED USE The HALOFLEX Energy Generator is indicated for use for the coagulation of soft tissue. The HALOFLEX System is indicated for use in the coagulation of bleeding and nonbleeding 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, Angiodysplasia, Gastric Antral Vascular Ectasia and Radiation Proctitis. EU, Canada: The HALOFLEX 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

CONTRAINDICATIONS This User Manual should be used in conjunction with the Instructions for Use provided with each type of disposable device. See Instructions for Use provided with the disposable device for the Contraindications.

4

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 medical staff. It is important that the operating instructions supplied with the Energy Generator be read, understood and followed before use. 4.1

WARNINGS 4.1.1

Energy Generator • Do not operate the Energy Generator before thoroughly reading this manual and the IFU for each disposable device. • 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 the generator if significant damage to the cover or front panel is detected as there is a risk of electrical shock. • 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 the supplied hydrophobic filter (included in all Balloon Catheter’s packaging), placed between the pneumatic connector located at the proximal end of both the Sizing Balloon and Ablation Catheter and the pneumatic connector line on the Output Cable to ensure fluids are not aspirated into the Output Cable in the event of a balloon 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. • Only inflate all HALO Balloon Catheters using the inflation system incorporated into the Energy Generator. • If the Energy Generator displays an E95 or C56 Operational Code, this is most likely caused by an air leak in the system. If the E95 or C56 Operational Codes are observed, under endoscopic visualization, manually deflate the balloon using a syringe via pneumatic connector at the proximal end of Ablation Catheter, remove and replace the catheter. 717-0014-01 (025-0170-000) Revision: D Page 2 of 43

• Visual endoscopic confirmation of complete balloon deflation must be performed prior to attempting to reposition or remove a Balloon Based Ablation Catheter or Sizing Balloon. • Do not deliver RF energy in areas containing surgical 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 patient leads or leads from other patient-connected equipment. Do not use the Output Cable if the insulation is damaged to prevent the risk of electrical shock. • 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 devices are planned to be used in patients with cardiac pacemakers. • This equipment is intended to be used by healthcare professionals only. • This equipment has been tested and complies with the limits for medical devices to the IEC 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. • This equipment may cause radio interferences or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the equipment or shielding the location. 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. • Generator contains a 3.3V Lithium Battery (Ref designator BTI) and a 5A 250V µ Fuse (Ref designator FI). These parts may only be replaced by BÂRRX authorized service personnel. There are no user-serviceable parts in this device. Refer servicing to qualified BÂRRX Medical, Inc. personnel by contacting BÂRRX Medical, Inc. at 888-662-2779 or 408-328-7310.

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4.1.2

Ablation Catheters • See HALO360+ Ablation Catheter or the HALO90 Ablation Catheter Instructions for Use (IFU). • Do not use the HALO360+ Ablation Catheter or HALO90 Ablation Catheter if the catheter insulation is damaged, as there is a risk of electrical shock.

4.1.3

Sizing Balloon • See HALO360+ Ablation Catheter and Sizing Balloon IFU.

4.2

PRECAUTIONS 4.2.1 Energy Generator • This System cannot be used at an elevation greater than 7000 feet (2,134 meters) above sea level or lower than 300 feet (91 meters) 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 HALOFLEX Footswitch model 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 Output Cable around metal objects. Wrapping cables around metal objects may induce hazardous currents. • Disconnect all cables after use. 4.2.2 Ablation Catheters •

See HALO360+ Ablation Catheter or the HALO90 Ablation Catheter Instructions for Use (IFU).

•

Ablation Catheter electrodes must be kept away from patient and user when not in use.

4.2.3 Sizing Balloon • 5

See HALO360+ Ablation Catheter and Sizing Balloon Instructions for Use (IFU).

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

5.1

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 non-conductive wheels. Refer to hospital procedures or local codes for detailed information.

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Provide at leaast four to sixx inches of space s aroundd the sides annd top of thee Energy G Generator forr convection cooling. Doo not prop thhe Energy Generator G on top of anythhing thhat will interrfere with itss underside clearance. c D not store items Do i directlly under the E Energy Generrator. Do noot stack Gennerators. Undder continuoous use for extended e periiods of time, it is normal n for thhe top and reear panel to be b warm. 5.2

M Mains Powerr Cord T Energy Generator The G is shipped withh an approveed hospital grade g mains power cord.. Do not use ex D xtension cordds or three-pprong to two-prong adappters. The mains m power cord c asssembly sho ould be perioodically checcked for dam maged insulattion or connectors.

5.3

Energy Geneerator Clean E ning and Diisinfection Instructions I s U a mild deetergent and damp cloth to clean the Energy Gennerator coverr, front paneel, and Use power cable. The Energyy Generator is i not sterilizzable. Do not allow fluiids to enter the t E Energy Generrator chassiss. The Energgy Generatorr may be dissinfected using a standarrd hospital alcoh hol solution applied withh a cloth or by b wiping doown equipmeent with soddium hyypochlorite 500 ppm wipes; leavingg it in contact with all surrfaces for 100min; then using a damp cloth cllean with neuutral detergeent. Do not expose the metal m pins off the connecttor to thhe sodium hy ypochlorite wipes w in ordder to prevennt corrosion. Do not spraay or pour liquids directly on th he unit. Figure 1A 1 - HALO OFLEX Energyy Generatorr Front View w with Footsswitch

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Figure 1B - HALOFLEX Energy Generator Rear View (Model 1190A-115A)

Figure 1C - HALOFLEX Energy Generator Rear View (Model 1190A-230A)

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Figure 1D – HALOFLEX Energy Generator Front View (Models: 1190A-115A & 1190A-230A)

5.4

HALOFLEX Energy Generator Controls A description of the control buttons and their functions are given below. Please refer to Figures 1A through 1D for the location of each item on the generator. 5.4.1

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 increases 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 decreases the display to the minimum allowable value.

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Graphic

Button Description RF POWER CONTROL – Starts and stops the output of radiofrequency energy. The switch flashes blue when the balloon is inflated and/or when energy is ready to be delivered. The switch is constantly illuminated with a blue lamp when RF energy is being delivered. The switch initiates RF energy delivery to HALO360+ or HALO90Ablation Catheter electrodes.

AUTOMATIC INFLATE OR DEFLATE CONTROL BUTTONS – Allows inflation or deflation of the HALO360+ Ablation Catheter and Sizing Balloon. (N/A to HALO90Ablation Catheter). 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. Note: HALO360+Ablation Catheter, automatically deflates after the delivery of RF energy is completed. RESET Button – Clears Operational Codes and recoverable codes. Does not clear unrecoverable codes.

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Graphic

Button Description CALIBRATE Button – Used to calibrate the Sizing Balloon. Calibration is performed on the Sizing Balloon to establish measurement accuracy.

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5.4.2

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 POWER ON Mode, there is no display. Range: 1 to 300 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: 1.0-99.9 J/cm2 BALLOON DIAMETER Display – Indicates diameter of organ as measured by the Sizing Balloon. Range: 1 to 99.9 mm

BALLOON PRESSURE 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 SYSTEM STATUS Display – The LCD display is used to display User instructions and Error and Operational Codes with 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.

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5.4.3

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 green 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 Mode.

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

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

5.4.4

Energy Generator Front Panel Receptacles and Connections Graphic

Description RF OUTPUT CABLE Connection – Provides the means for delivering radiofrequency energy to the Ablation Catheter and a means for determining the size/type of catheter connected. Next to this electrical connector is the pneumatic connector for use with the HALO360+Ablation Catheter and Sizing Balloon.

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5.4.5

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.

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. USB Port – For manufacturing and testing purposes by BÂRRX Medical, Inc. personnel only.

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6 6.1

ENERGY GENERATOR AND ACCESSORIES Introduction The HALOFLEX Energy Generator, Models 1190A-115A & 1190A-230A, delivers radiofrequency energy at 460 kHz in a bipolar mode to the Ablation Catheter. The Energy Generator includes an inflation system for Balloon Based Catheters. The Energy Generator measures and displays treatment power, energy density, balloon size and balloon pressure.

6.2

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. When ancillary equipment is connected to the signal input part or signal output part of the HALOFLEX Energy Generator, it is recommended to connect such equipment to the power outlet through a separation transformer and therefore to comply with the requirements of the system standard IEC 60601-1. If in doubt, consult the technical services department or your local representative. 6.2.1

HALOFLEX 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 POWER CONTROL ON/OFF Button and the AUTOMATIC INFLATE Up and DEFLATE Down Buttons. The Footswitch Unit houses two Foot Pedals, the basic operation of each Foot Pedal is: press once and release to engage, and press once and release to disengage. 6.2.1.1

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 Foot 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 a Balloon Based Ablation Catheter is connected, the Energy Generator will inflate the balloon to the Ablation Catheter inflation pressure. ¾ If a Non-Balloon Based Ablation is connected, this Foot Pedal function will be disabled. •

A successive depression of this Foot Pedal will automatically deflate the balloon to a minimum of -0.136 atm (-2.0 psi).

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6.2.2

6.2.1.2

The other Foot Pedal is labeled “RF POWER ON/OFF” and initiates delivery of RF energy in the same manner as the RF POWER CONTROL 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 POWER 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). • If RF energy is active and the user releases the Foot Pedal, and then depresses the foot pedal a second time, RF energy delivery ceases. CAUTION: Do not continually hold down or repeatedly depress RF POWER ON/OFF Foot Pedal during the procedure.

6.2.1.3

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

6.2.1.4

Disconnect Footswitch after use. Do not wrap Footswitch Cable excessively tight around Footswitch.

HALOFLEX Output Cable The Output Cable is a reusable cable that connects the Sizing Balloon and the Ablation Catheters to the Energy Generator. The Output Cable contains both the electrical and pneumatic conductors required to interface the Sizing Balloon and Ablation Catheters to the HALOFLEX Energy Generator. It allows the Energy Generator to control inflation and deflation of Balloon Based Ablation Catheters and Sizing Balloons. The Output Cable is also the source for delivering power to Ablation Catheters. The Output Cable is approximately 9’ in length and 3/4” in diameter. The Output Cable terminates into a 10 pin electrical connector (4 for RF and 5-6 for electrical signals) at both ends, and a male luer pneumatic fitting on the catheter end and a female luer pneumatic fitting at the generator end. 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. Disconnect Output Cable after use.

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6.2.3

Disposable Devices The HALOFLEX Energy Generator is compatible with the following disposable devices: Disposable Type

Balloon Based Ablation Catheters

Non Balloon Based Ablation Catheters Sizing Balloons

Model # 32041-18

Description 18 mm HALO360+ Ablation Catheter

32041-22

22 mm HALO360+ Ablation Catheter

32041-25

25 mm HALO360+ Ablation Catheter

32041-28

28 mm HALO360+ Ablation Catheter

32041-31

31 mm HALO360+ Ablation Catheter

90-9100

HALO90 Ablation Catheter

3441-B

HALO360 Sizing Balloon

3441-C

HALO360+ Sizing Balloon

For procedural usage steps and a description for each device, see the Instructions for Use provided with the disposable device. 7

SET-UP PROCEDURE AND INSTRUCTIONS FOR USE

7.1

Connection of Accessories 7.1.1

Output Cable Connections Connect the provided Output Cable to the Energy Generator by attaching the large, electrical connector on the Output Cable to the mating connector on the front panel of the Energy Generator. Place the white alignment dot on the large electrical connector at 12 o’clock position for proper pin alignment. Once the pins have been mated correctly, tighten the threaded exterior connector ring to secure the Output Cable to the Energy Generator. Connect the pneumatic line adjacent to the large, electrical connector on the Output Cable to the male luer connection on the front panel of the Energy Generator. Press the Output Cable bayonet style connector firmly against the Energy Generator connection until the connectors snap together.

7.1.2

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. Place the white alignment dot on the footswitch connector at 12 o’clock position for proper pin alignment. Once the pins have been mated correctly, tighten the threaded exterior connector ring to secure the Footswitch to the Energy Generator.

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7.1.3

Catheter Connections The Sizing Balloon and Ablation Catheter pneumatic and electrical connectors are connected to the Energy Generator using the Output Cable that is supplied with the Energy Generator. Prior to connecting the Output Cable pneumatic line connector to any Sizing Balloon or Balloon Based Ablation Catheter, it is necessary to place the supplied hydrophobic filter between the pneumatic connector located at the proximal end of the Sizing Balloon or Ablation Catheter and the pneumatic connector on the distal end of the Output Cable. This filter is 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 catheter connection only when the Energy Generator is powered OFF or is in the STANDBY Mode.

7.2

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 ‘Self Test In Progress’ 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 twenty to twenty-five 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.

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7.3

Energy Generator Modes The Energy Generator operates in one of seven modes, POST (Power ON Self Test), STANDBY, CATHETER CONNECTED, ACTIVE (RF ON), ABLATION COMPLETE, ERROR, and FAULT. Refer to Figure 2. Figure 2 - State Diagram of HALOFLEX Energy Generator Modes

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7.3.1

POST (Self-Test) Mode The POST is performed when AC mains power is turned on. The following tests are performed: •

A test of the CPU and RAM

•

A test of the CPU and ROM

•

A test of the CPU Configuration

•

A test of the CRC of the program contents

•

A test of the watchdog shutdown hardware

•

A test of the power

•

A test of the impedance

•

A test of the voltage

•

A test of the current

•

A test of the reference voltage

•

A test of the real time clock

•

A test of the inflation subsystem’s pressure sensors for zero offset and transducer calibration

•

A test of the air pump operation

•

A test of the displays and indicators (must be confirmed by an observer)

•

A test of the audible indicator (must be confirmed by an observer)

•

A test for switch and foot switch pressed

•

The RF Generator’s software version number is displayed on the LCD panel for a minimum period of 2 seconds System Transitions

7.3.2

•

If all self-tests pass, the system transitions to the STANDBY Mode.

•

If self-test fails, the result is monitored by the system, the system will automatically transition to the FAULT Mode. In the FAULT Mode, the LCD will display instructions to the User to resolve the FAULT condition. Since the system does not monitor display indicators nor the audible indicator, failures of these features during self-test will not result in a transition to the FAULT Mode.

STANDBY Mode 7.3.2.1

The Standby Mode is automatically entered following a successful POST and displays “Ready Connect Catheter” on the LED Display.

7.3.2.2

None of the User controls are accessible when the system is in the Standby Mode.

7.3.2.3

The system will remain in the Standby Mode until a catheter is connected, then will enter the CATHETER CONNECTED Mode.

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