Ethicon Gynecare ThermaChoice II User manual

ThermaChoice UBT System Service Manual
P/N 01035 Rev. C
THERMACHOICE
™
II UBT System
Service Manual

ThermaChoice UBT System Service Manual
P/N 01035 Rev. C
About This Document
Overview
The THERMACHOICE™II UBT 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 THERMACHOICE™II UBT catheter is designed for use only with the
THERMACHOICE™II UBT controller.
Purpose
The THERMACHOICE™II UBT System Service Manual is to be used as a guide
to maintaining and servicing the THERMACHOICE™II UBT System.
Scope
This manual is to be used by all personnel responsible for maintaining and
servicing the THERMACHOICE™II UBT 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 (FRU) 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
P/N 01035 Rev. C
How to Use This Guide
The GyneCare THERMACHOICE™II 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 THERMACHOICE™II UBT System. Later sections will
provide details for troubleshooting the individual FRUs, removal and replacement
of failed FRUs, and additional reference information.
Organization
Section One contains an overview of the system. It includes descriptions 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 electrical 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
P/N 01035 Rev. C
Contents Section-Page
System Overview 1-1
Device Description
Indications
Precautions
Functional Description of Circuits
Diagnostics and Troubleshooting 2-1
Diagnostic Error Codes 2-1
Troubleshooting Decision Trees
Field Replaceable Unit Listing 3-1
Table of Field Replaceable Units 3-1
Catalog of Field Replaceable Units 3-2
Repair Procedures 4-1
Assembly, AUX Board 01204 4-1
Assembly, ISO Board 00983 4-2
Power Supply 00808 4-4
Power Entry Module (PEM) 01353 4-7
Assembly, Motor Drive Unit (MDU) 01014 4-8
Heater Fuse 01620 4-10
Power Entry Module Fuse 00861 4-11
Assembly, Micro (Micro) 01200 4-11
LCD Display 00877 4-13
Switch, Power, Mains 01033 4-14
Power Entry Cable 00868 4-16
Power Supply Cable 00855 4-17
ISO Micro Cable 01504 4-18
CCS Switch Cable 01293 4-19
Ribbon Cable, 40 Cond. 00874 4-20
Assy, Cable, Surge Arrestor 01347 4-21
Maintenance 5-1
Calibration 5-1
Pressure Calibration 5-1

ThermaChoice UBT System Service Manual
P/N 01035 Rev. C
Schematics A-1
Functional Block Diagram
Wiring Diagram
Detailed Schematics
Electrical/Electronic Parts List B-1
THERMACHOICE™II UBT System Operating Manual C-1

ThermaChoice UBT System Service Manual 1 - 1
P/N 01035 Rev. C
Section One
System Overview
Figure 1-1
Device Description
The THERMACHOICE™II UBT 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 THERMACHOICE™II UBT catheter is designed for use only with the
THERMACHOICE™II UBT 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 – D
5
W) 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 (188°F) for 8 minutes.
The THERMACHOICE™II UBT 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 1 - 2
P/N 01035 Rev. C
c) Balloon catheter version 1.2: This version does not have a fluid circulation
mechanism inside the balloon.
Indications
The THERMACHOICE™II UBT System is a thermal 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 THERMACHOICE™II 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 1 - 3
P/N 01035 Rev. C
Product Overview
The THERMACHOICE™II 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, stirring 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

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P/N 01035 Rev. C
Motor Drive 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 ±12
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 TC1,
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 TC1 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.

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P/N 01035 Rev. C
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 ICs (AD595
thermocouple amps). These ICs are thermally bonded to the cold junctions. Each
IC 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 HCII 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 1 - 6
P/N 01035 Rev. C
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_1_ON* and HEATER_2_ON*. HEATER_1_ON* enables the
switching IC in the power supply. HEATER_2_ON* 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 °target within four minutes to prevent a
hazard from shutting the system down.
Microprocessor Circuitry
The microprocessor used in the system is a Motorola 68HC11. 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 U15 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 burn-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 1 - 7
P/N 01035 Rev. C
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 1 - 8
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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
Mains Fuses 250VAC, 5x20 mm 1.6A standard
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 (15.3 lbs.) (controller only)
Case Aluminum and impact-resistant plastic
Umbilical Cable Length 152 cm (60 in.)
ENVIRONMENTAL CONDITIONS
Transport and Storage
Ambient temperature -20 to +50
o
C
Relative humidity 20% to 85% non-condensing
Operation
Ambient temperature 10 to 40
o
C
Relative humidity 20% to 85% non-condensing
Electromagnetic Compatibility
ESD Direct & Indirect: Conforms to IEC 601-1-2
EMI Conforms to IEC 601-1-2
Leakage Currents
Patient Leakage Current Conforms to IEC 601-1
Earth Leakage Current Conforms to IEC 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 2- 1
P/N 01035 Rev. C
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
Blank Display w/ Audio Micro or Display
00, 01, 02, 03, 12 Micro If unit consistently
displays these unused
error codes
MDU Warning MDU
17 PS or Micro
26, 29, 30 AUX or Micro
28, 31, 33, 35 ISO or Micro
50,.58, 68 Disposable or Umb or ISO or
Placement
59, 60, 61, 64 66 AUX or PS Test Procedure Update
Required, Check output
of TP19, and TP31
62, 63 Micro or Pressure F
ittings & Lines
65 AUX or ISO or Micro
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 UBT System Service Manual 2- 2
P/N 01035 Rev. C
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 3 - 1
P/N 01035 Rev. C
Section Three
Field Replaceable Units
Assy,
Motor
Drive Unit
PN 01014
Switch,
Power,
Mains
PN 01033
(on front
bezel)
Assy, AUX
PN 01204
Power Entry
Module
PN 01353
Power
Supply
PN 00808
Assy, ISO,
PN 00983
Assy, Micro
PN 01200
(behind front
bezel)
Display, LCD
PN 00877
(on Micro
Assy, w/ Flex
cable
attached)

ThermaChoice UBT System Service Manual 3 - 2
P/N 01035 Rev. C
Assy, Cable,
GND,
EQPOST-
CHASSIS
PN 00866
Assy, Cable,
ISO-Micro
PN 01504
Assy, Cable,
Surge
Arrestor
PN 01347
Assy, Cable,
Ribbon, 40
Cond, 3.5”
PN 00874
Assy, Cable,
CCS_SWITCH
PN 01293
(shown as dotted
line for location)
Assy, Cable,
PWR,ENTRY
PN 00868
Assy, Cable,
GND-PS-
CHASSIS
PN00864
Assy, Cable,
DC 150W
PN 00855

ThermaChoice UBT System Service Manual 3 - 3
P/N 01035 Rev. C
Table of Field Replaceable Units
Common Name Bill of Materials Designation Assy No.
AUX Board ASSY,PCBA,AUXILLARY 01204
ISO Board ASSY,PCB,ISO 00983
Micro Board ASSY,PCBA,MICROPROCESSOR 01200
Motor Drive Unit (MDU) ASSY,MOTOR DRIVE UNIT 01014
Power Supply PSUPPLY,UNIV INPUT,+5V,-24V-/-12V 00808
Power Entry Module (PEM) PEM,FILTER,W/FUSEHOLDER 01353
Power Switch, Mains SWITCH,SPDT,AMP,.187”TERM,MDU 01033
LCD Display DISPLAY, 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 3 - 4
P/N 01035 Rev. C
AUX Board
ASSY,PCBA,AUXILLARY
PN 01204
ISO Board
ASSY,PCBA,ISO
PN 00983
Micro Board
ASSY,PCBA,
MICROPROCESSOR
PN 01200

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P/N 01035 Rev. C
Motor Drive Unit
ASSY,MOTOR DRIVE UNIT
PN 01014
Power Supply
PSUPPLY,UNIV INPUT,+5V,-24,V-
/-12V
PN 00808
(ground cable not included)
Power Entry Module
PEM,FILTER,
W/FUSEHOLDER,
3A,.250"TERM
PN 01353