THERMACHOICE II UBT System Service Manual Rev C

About This Document Overview The THERMACHOICETMII VBT System is a software-controlled device designed to ablate uterine tissue by thermal energy. The system is comprised of a single-use balloon catheter, a reusable controller, umbilical cable, and power cord. The THERMACHOICETMII VBT catheter is designed for use only with the THERMACHOICETMII VBT controller.

Purpose The THERMACHOICETMII UBT System Service Manual is to be used as a guide to maintaining and servicing the THERMACHOICETMII VBT System.

Scope This manual is to be used by all personnel responsible for maintaining and servicing the THERMACHOICETMII VBT System. It provides procedure level detail on maintenance and service. Troubleshooting and repair is to be performed on the system down to the level of field replaceable units (FRV) rather than to the component level.

Audience Description The primary audience for the manual is trained GyneCare repair personnel, Colorado MEDtech manufacturing personnel, hospital maintenance personnel and biomedical technicians responsible for performing specific maintenance and service operations on-site.

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

How to Use This Guide The GyneCare THERMACHOICETMII UBT Service Manual is an important resource when performing maintenance and service. Read the entire document to become familiar with its content and structure. Use Section One to get an overall understanding of the THERMACHOICETMII UBT System. Later sections will provide details for troubleshooting the individual FRUs, removal and replacement of failed FRU s, and additional reference information.

Organization Section One contains an overview of the system. It includes descliptions of the mechanical and electronic sub-systems. Section Two covers diagnostics and troubleshooting to help locate the causes of typical system failures, including a table of diagnostic error codes and their meaning and a troubleshooting guide. Section Three details the field replaceable units including photographs and part numbers. Section Four covers remediation, including removal and replacement procedures for field replaceable electlical and mechanical assemblies and a procedure for returning the instrument for repair. Section Five details the maintenance of the system including pressure and temperature calibration, fuse and power cord replacement, cleaning, and disinfection. Appendix A contains detailed schematics including the functional block diagram, wiring diagram, and discrete components diagram. Appendix B contains electrical/electronic parts lists and component values. Appendix C contains a copy of the Operating Manual.

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

Contents

Section-Page

System Overview Device Description Indications Precautions Functional Description of Circuits

1-1

Diagnostics and Troubleshooting

2-1

Diagnostic Error Codes Troubleshooting Decision Trees

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Field Replaceable Unit Listing Table of Field Replaceable Units Catalog of Field Replaceable Units

3-1

Repair Procedures Assembly, AUX Board Assembly, ISO Board Power Supply Power Entry Module (PEM) Assembly, Motor Drive Unit (MDU) Heater Fuse Power Entry Module Fuse Assembly, Micro (Micro) LCD Display Switch, Power, Mains Power Entry Cable Power Supply Cable ISO Micro Cable CCS Switch Cable Ribbon Cable, 40 Cond. Assy, Cable, Surge Arrestor

3-1 3-2

4-1 01204 00983 00808 01353 01014 01620 00861 01200 00877 01033 00868 00855 01504 01293 00874 01347

Maintenance Calibration Pressure Calibration

ThermaChoice UBT System Service Manual PIN 01 035 Rev. C

4-1 4-2 4-4 4-7 4-8 4-10 4-11 4-11 4-13 4-14 4-16 4-17 4-18 4-19 4-20 4-21

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Schematics Functional Block Diagram Wiring Diagram Detailed Schematics

A-I

ElectricallElectronic Parts List

B-1

THERMACHOICETMJI UBT System Operating Manual

C-l

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

Section One System Overview rSIN GLE USE CATHETE R BALLOO N

IIvlPELLER

HEATING AN D SENSING ELEMENTS

/

__. bYRINGE

CATHETER Ut"1BILl C/ l~~----__ CABLE CO N ~,J EeTI ON ----...:

Figure 1-1

Device Description The THERMACHOICETMII VBT System is a software-controlled device designed to ablate uterine tissue by thermal energy. The system is comprised of a single-use balloon catheter, a reusable controller, umbilical cable, and power cord. The THERMACHOICETMII VBT catheter is designed for use only with the THERMACHOICETMII VBT controller. The balloon catheter is 1) connected to the controller, 2) inserted through the cervix into the uterus, 3) filled with sterile, injectable fluid (plain 5% dextrose in water - DsW) carefully stabilizing the pressure to 160-180 mmHg pressure, and 4) activated to thermally ablate endometrial tissue by maintaining a temperature of approximately 87°C (l88°P) for 8 minutes. The THERMACHOICETMII VBT controller is designed to work with 3 different versions of the balloon catheter. They are: a) Balloon catheter version 2.0: This balloon catheter has a fluid circulation mechanism inside the balloon. b) Balloon catheter version 1.4: This version does not have a fluid circulation mechanism inside the balloon. ThermaChoice UBT System Service Manual PIN 01035 Rev. C

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c) Balloon catheter version 1.2: This version does not have a fluid circulation mechanism inside the balloon.

Indications The THERMACHOICETMII UBT System is a thelmal ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.

Functional Description of Circuits Purpose The purpose is to describe the THERMACHOICETMII Uterine Balloon Therapy (UBT) system and to give an overview of the functional components that make up the electronic unit, referred to as the controller. The document as written should aid the technician in troubleshooting the product for service and manufacturing assembly.

Scope This document is limited to the controller.

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

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Product Overview The THERMACHOICETMII Uterine Balloon Therapy (UBT) system is an instrument designed to ablate endometrial tissue in the uterus, where excessive uterine bleeding is diagnosed. A balloon on a semi-rigid plastic catheter containing a resistive heating element is inserted into the uterus and manually filled with sterile D5W to a pre-specified pressure range. The fluid is then heated to 87° C and maintained at that temperature for the duration of the 8-minute therapy cycle. The UBT system normalizes or alleviates the excessive uterine bleeding by ablating the endometrial lining within the uterus utilizing a thermal ablation technique. The thermal ablation process uses heated fluid to cause endometrial tissue necrosis during the treatment cycle. The fluid in the balloon is maintained under pressure to increase the balloon surface area contact with the endometrium and to reduce the blood flow to the endometrium by tissue compression and hence increase the thermal ablation penetration. The UBT system consists of a controller, a disposable catheter, an umbilical cable, and a power cord. The catheter houses the heating element and two thermocouples in the balloon and a stirring device in newer models. The pressure transducer is internal to the controller with the pressure port located on the front panel of the controller. The fluid transport mechanism is manual and external to the controller. The UBT controller is a microprocessor based system with a LCD for displaying messages, LED displays for displaying time, temperature, and pressure, and alarms. To use the system, the catheter is first connected to the controller via the umbilical cable pressure line to the pressure port and motor drive unit (MDU) port, on the front panel of the controller. The power is then turned on. After purging the balloon and its placement into the uterus, the balloon is filled with sterile D5W to a pre-specified pressure. Pressing the start button will initiate the preheat cycle. Once the desired temperature is reached the controller will start the therapy cycle. Heating is automatically stopped after the therapy cycle is completed or if a fault is detected. The LCD display along with LED displays and alarms, inform the user of the status of the procedure and the pertinent parameters, pressure, temperature, stin-ing status, and time throughout the procedure. The background diagnostic routines continuously monitor the integrity of the controller operations.

Functional Sections Power Supplies and Isolation Temperature Measurement Pressure Measurement Heater Drive and Protection ThermaChoice UBT System Service Manual PIN 01035 Rev. C

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Motor Dlive Unit (MDU) Central Processing Unit (CPU) User Interface, Front Panel Display For more information regarding the procedure set up, operation of the device, messages, error conditions, unit calibration, etc. refer to Appendix A of the User Manual.

Transformer, Power Supplies and Isolation The system operates on 100 to 240 VAC and 60 Hz power lines. The line operated power supply is auto input ranging and needs no adjustment. The power entry module consists of a conducted line noise filter and a sub-module with two fuses. The two fuses break neutral and line. The front panel power switch breaks the line and neutral side of the primaries between the rear power module and the power supply. The line operated power supply is medical grade. The power supply also provides 4000 Volts of reinforced (Double-Plus) isolation between the primary and at the secondary side. The power supply outputs +24V, +5V, +12V, -12V. The 24 Volts is used for the MDU and heater. The 5 Volts is used for logic power. The ±1 2 Volts are used for analog circuitry. (See Functional Block Diagram in Appendix A.)

The thermocouple amplifiers and their power up test circuitry are powered by two isolated +5V to ±12-Volt power supply. The isolation is to allow proper thermocouple operation in proximity to the heater and not to isolate the patient. The block diagram in Appendix A illustrates the system power supply configuration as well as interactions of different subsystems of the unit. As indicated, the communication between different subsystems is accomplished serially through the use of analog isolation amplifiers. The power supply is of a switching type with the ±12 Volts being linearly regulated.

Temperature Measurement The temperature measurement inside the catheter balloon is accomplished by using two "K" type thermocouples. One of the thermocouples, referred to as TCI, is used as the feedback in controlling the heater. The value of this thermocouple is displayed by one of the LED displays on the controller front panel. The second thermocouple reading is used only as a check against TC I reading. This value is not displayed. The low level thermocouple signals are transmitted to the controller via the umbilical cable. The raw signals are amplified by use of thermocouple amplifiers. ThermaChoice UBT System Service Manual PIN 01035 Rev. C

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These are two of the nine inputs to the multiplexing analog-digital converter (ADC). The ADC is a high precision serial ADC that operates from an independent voltage source and a 5.000 VDC precision voltage reference. The positive and negative terminals of each of the two thermocouples are connected to the inputs of the amplifiers through two single pole double throw relays. These relays are used at power up to switch the inputs of the amplifiers to a 3.25 mV reference to check for any accuracy in the measurement channels. The cold junction compensation is done by the thermocouple lCs (AD595 thermocouple amps). These lCs are thermally bonded to the cold junctions. Each lC measures the offset caused by the cold junctions and adds it to the output voltage of the thermocouples, which produces the corrected measured temperature.

Pressure Measurement The balloon pressure measurement is accomplished by the use of two pressure transducers inside of the controller. The catheter balloon is connected to the pressure port located on the front panel of the controller via a pressure tube. The port is in turn connected to the transducers inside the controller unit. To stop the fluid from flowing back inside the controller when the catheter is pressurized, the catheter pressure line is equipped with a filter that is permeable to air only. The transducer is of a differential type, which measures the balloon pressure relative to the atmospheric pressure. The pressure measurement is similar to that of the temperature measurement. The raw transducer signals are amplified and fed to the multiplexing ADC. These transducers need to be biased approximately halfway in their output range so they can output negative pressures. There is no adjustment for this zero point so each new unit must be calibrated by entering calibration mode. The zero point of each transducer is measured (with no pressure port attachment) and written into the nonvolatile memory of the 68 HCn microprocessor.

Heater Drive and Protection Circuitry The software that controls the heater uses a proportional - integral algorithm that varies the power from 0 to 60 watts to heat and maintain the temperature of the fluid. During heat up, the power is limited if the temperature ramps faster than 2 degrees per second leading to a minimum heat up time of about 30 seconds. The software heater control algorithm regulates to a constant set point of 87° C after the initial heat up.

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

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The current in the heater is constantly monitored while the heater voltage is greater than 2.8 volts. If the current is less than 0.14 amps or greater than 2.5 amps, the controller will shut down with and generate an Error 65 . If the heater voltage varies more than +/- 10% from the desired control voltage, the same error is generated. The heater is powered from a 28 VDC SEPIC (Single Ended Primary Inductance Converter) topology regulator. The heater load is nominally at 13.2 ohms. Therefore, the nominal current of the heater is about two amps. The SEPIC regulator has three control inputs. 1) 0 - 5 volts in to control; 0 - 28 volts out. 2) HEATER_I_ON:' and HEATER_2_0N:'. HEATER_I_ON:' enables the switching IC in the power supply. HEATER_2_0N:' enables a series pass transistor to the heater and simultaneously disables a short circuit short transistor. These transistors cannot both be on at the same time. If this were to happen, the shunt transistor would draw all of the SEPIC output through a 4 amp fuse, blowing it. This is to cover the short circuit failure of the series pass transistor. During preheat, the temperature is checked to make sure it is rising at least 2 degrees every 10 seconds. This test is intended to catch the unlikely dual fault condition of two shorted thermocouples. If the measured temperature persistently fails to meet the criteria for 30 seconds, an error is declared. The temperature must also reach the 87 0 target within four minutes to prevent a hazard from shutting the system down.

Microprocessor Circuitry The microprocessor used in the system is a Motorola 68HCII. The processor runs at 8 MHz. The processor controls the digital displays, LCD, Alarm LED, Beeper, Start LED, therapy sequence of events, timing, heater on/off control, and RS-232 port. Support components are the 2KB Static Memory (RAM), 56KB Electronically Programmable Read Only Memory (EPROM), and address decoding. These devices are all contained in VI5 on the microboard. This one-time programmable part is a WSI PSD312-P. A special test mode or calibration mode places the unit in constant therapy cycle. The constant therapy cycle is used for bum-in testing. The Static RAM stores intermediate values being temporarily stored by the microprocessor. This information is lost if power is turned off. The EPROM stores the operational software for the processor. The RS232 serial port is used only in manufacturing and for investigational purposes. It is not intended to be used by the end user. It can be used to display both thermocouples and both pressure transducer readings. ThermaChoice UBT System Service Manual PIN 01035 Rev. C

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Front Panel Display, User Interface The power switch is located on the front panel. It is an illuminated switch that breaks both line and neutral of the AC line on the primary side of the transformer. The thermocouple temperature of the catheter, the pressure of the balloon, and the time of the procedure are displayed by three LED seven segment type displays. A sixteen by two character backlit LCD on the front panel is used as a message center, informing the user of the status of the unit and the procedure. The front panel also includes two membrane type switches. The START and the STOP switch. The START switch is used to start the PREHEAT cycle of the procedure. This switch is enabled once the balloon pressure titration has been completed. The activation of the STOP switch turns the heater off and terminates the procedure. A green start light indicator on the front panel further informs the user that the procedure can start. This light blinks when the START button is enabled. There is also a yellow hazard indicator on the front panel. This indicator lights up when a hazard condition is encountered and the system is stopped. Two audio generators simultaneously sound all alarms. The frequency components of the Alerts and Alarms are EN475 compliant. Upon powering on the unit, the audio generators make a distinctive ding dong sound. If either the "ding" or "dong" does not sound, one of the audio generators on the AUX board is defective.

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

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Specifications POWER SOURCE (Controller) Power Requirements 100 to 240VAC; 50/60 Hz; 110 watts; 3-wire grounded system Regulation Voltage 90 to 264VAC, 47-63 Hz, single phase 250VAC, 5x20 mm 1.6A standard Mains Fuses Heater Fuse 250VAC, 4.0A slo-blo MECHANICAL CHARACTERISTICS Dimensions Height 10.2 cm (4 in.), width 41.2 cm (16.25 in.), depth 37.0 cm (14.56 in.) Weight 6.9 kg (15.31bs.) (controller only) Aluminum and impact-resistant plastic Case Umbilical Cable Length 152 cm (60 in.) /

ENVIRONMENTAL CONDITIONS Transport and Storage Ambient temperature -20 to +50°C Relative humidity 20% to 85% non-condensing Operation Ambient temperature 10 to 40°C Relative humidity 20% to 85% non-condensing Electromagnetic Compatibility ESD Direct & Indirect: Conforms to lEC 601-1-2 EMI Conforms to lEC 601-1-2 Leakage Currents Patient Leakage Current Conforms to lEC 601-1 Earth Leakage Current Conforms to lEC 601-1

Electromagnetic Interference In general, sensitive electronic equipment should always be positioned as far away as possible from sources of high frequency voltages and currents, such as electrosurgical generators. Moreover, cables connected to high frequency sources should be kept as short as possible and must never be routed near or parallel to cables of sensitive equipment.

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

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Section Two Diagnostic and Troubleshooting Guide Error Codes The instrument will perform a power-up self test every time the unit is started. If an error is detected, it will appear on the display if possible. Note: The Error Code Format is: xxyy, where xx=error code and yy=system state. Reference the first two numbers on the display for use with the table below. Problem or Error No.

Probable Source of Problem

Notes

Blank Display no Audio

Power Supply, Micro Board, Display, ISO Board, or AUX Board Micro or Display Micro

If unit consistently

Blank Display w/ Audio 00,01,02,03,12

displays these unused error codes MDUWaming 17 26,29,30 28,31,33,35 50,.58,68

MDU PS or Micro AUX or Micro ISO or Micro

Disposable or Umb or ISO or

59,60,61,6466

Placement AUXorPS

62, 63 65

Micro or Pressure Fittings & Lines AUX or ISO or Micro

Test Procedure Update Required, Check output ofTP19, and TP31

Diagnostic and Troubleshooting Decision Trees The following pages contain diagnostic and troubleshooting flowcharts. Warning: The following diagnostic and troubleshooting flowcharts, the repair procedures in Section Four, and the controllers's start-up diagnostic test will not detect faults in the heater circuit or the motor drive unit. If you suspect a problem with either of these field replaceable units, send the device to the authorized Gynecare service center. Notes:

1. Decision trees cover single faults.

ThermaChoice VBT System Service Manual

PIN 01035 Rev. C

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2. First troubleshooting step should be to perform a visual inspection of the connectors making sure they are seated properly. 3. Check FRUs by swapping out the suspect FRU with a known good FRU. 4. Replace the Micro Assembly to correct problems with the Pressure display, Temperature display, Time display, Start Button Light, or the Hazard Light. 5. Replace the Front Panel Assembly to fix problems with the Start and Stop buttons. 6. Replacement of the Motor Drive Unit (MDU) may be required if the instrument consistently displays the MOTOR FAULT WARNING using known good catheters.

ThermaChoice UBT System Service Manual

PIN 01035 Rev. C

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Section Three Field Replaceable Units Power Entry Module PN 01353

Switch, Power, Mains PN 01033 (on front bezel)

Assy, ISO, Assy, PN 00983 Motor Drive Unit PN 01014

Power Supply PN 00808

Assy, Micro PN 01200 (behind front bezel)

Display, LeO PN 00877 (on Micro Assy, wl Flex cable attached)

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

Assy, AUX PN 01204

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Assy, Cable, GND, EQPOSTCHASSIS PN 00866

Assy, Cable, PWR,ENTRY PN 00868

Assy, Cable, Surge Arrestor PN 01347

Assy, Cable, DC 150W PN 00855

Assy, Cable, GND-PSCHASSIS PN00864

Assy, Cable, ISO-Micro PN 01504

Assy, Cable, Ribbon , 40 Cond,3.5" PN 00874

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

Assy, Cable, CCS_SWITCH PN 01293 (shown as dotted line for location)

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Table of Field Replaceable Units

Common Name

Bill of Materials Designation

ASSI No.

AUXBoard

ASSY,PCBA,AUXILLARY

01204

ISO Board

ASSY,PCB,ISO

00983

Micro Board

ASSY,PCBA,MICROPROCESSOR

01 200

Motor Drive Unit (MDU)

ASSY,MOTOR DRIVE UNIT

01014

Power Supply

PSUPPLY,UNIV INPUT,+5V,-24V-i-1 2V

00808

Power Entry Module (PEM)

PEM,FILTER,WIFUSEHOLDER

01 353

Power Switch, Mains

SWITCH,SPDT,AMP,.187"TERM,MDU

0 1033

LCD Display

DISPLA Y, LCD,16X2,BACKLIT

00877

Heater Fuse

Fuse, 5X20MM, SLOWBLOW, 4.0A,250

01620

Power Entry Module Fuse

Fuse, 5X20MM, FASTBLOW, 1.6A,250

00861

Eqpost Ground Cable

Assy, Cable, GND, EQPOST-CHASSIS

00866

Power Entry Cable

Assy, Cable, PWR, ENTRY

00868

Ribbon Cable

Assy, Cable, RIBBON, 40 COND, 3.5"

00874

CCS Switch Cable

Assy, Cable, CCS_SWITCH

01293

ISO-Micro Cable

Assy, Cable, ISO-MICRO

01504

Power Supply Cable

Assy, Cable, DC, 150W

00855

Power Supply Ground Cable

Assy, Cable, GND-PS-CHASSIS

00864

Surge Arrestor Cable

Surge Arrestor Cable

01347

ThermaChoice UBT System Service Manual PIN 01035 Rev. C

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AUXBoard ASSY,PCBA,AUXILLARY PN 01204

ISO Board ASSY,PCBA,ISO PN 00983

Micro Board ASSY,PCBA, MICROPROCESSOR PN 01200

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Motor Drive Unit ASSY,MOTOR DRIVE UNIT PNOIOl4

Power Supply PSUPPLY,UNIV INPUT,+5V,-24,V1-12V PN 00808 (ground cable not included)

Power Entry Module PEM,FIL TER, W/FUSEHOLDER, 3A,.250"TERM PN01353

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