Belmont Medical Technologies CritiCool User manual

CritiCool
®
Thermoregulation
Service Manual
FDT-200-000 Rev J English

CritiCool
®
Service Manual
BELMONT MEDICAL TECHNOLOGIES
FDT-200-000 Rev J
2
Conformity according to the Council Directive 93/42/EEC
Manufactured for:
Belmont Medical Technologies
780 Boston Road
Billerica, MA 01821 USA
Technical Service
885-397-4547 (USA)
[phone] (WORLDWIDE)
www.BelmontMedTech.com
European Representative:
Emergo Europe BV
Prinsessegracht 20
2514 AP The Hague
The Netherlands
Switzerland Authorized Representative:
Medenvoy Switzerland
Gotthardstrasse 28
6302 ZUG
Switzerland
© by Belmont Medical Technologies. All RIGHTS RESERVED. Registered trademarks are the
intellectual property of their respective holders.

CritiCool
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TABLE OF CONTENTS
Definitions .............................................................................................................................11
Applicable Systems ...............................................................................................................11
Essential Performance ..........................................................................................................11
End of Service Life Policy......................................................................................................11
Intended Use.........................................................................................................................12
Testing After Servicing the System........................................................................................12
Warnings ...............................................................................................................................12
Precautions ...........................................................................................................................13
EMC Safety ...........................................................................................................................14
Improper Use.........................................................................................................................14
Equipment Disposal and Recycling .......................................................................................14
Labels....................................................................................................................................15
CritiCool Device Labels......................................................................................................15
Symbols.............................................................................................................................16
CritiCool
®
System..................................................................................................................18
External Features ..................................................................................................................19
Front View..........................................................................................................................19
Side View...........................................................................................................................20
Rear Panel.........................................................................................................................20
Accessories...........................................................................................................................22
Pre-installation Requirements................................................................................................23
Space and Environmental Requirements ...........................................................................23
Electrical Requirements .....................................................................................................23
Inspection Prior to Unpacking................................................................................................23
Unpacking the CritiCool Device .............................................................................................24
Assembling the Handle..........................................................................................................25
Accessory Kits.......................................................................................................................26

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Moving the Unit .....................................................................................................................27
Locking and Unlocking the Trolley Wheels.........................................................................28
Storage Environment.............................................................................................................28
Covers Assembly ..................................................................................................................29
Removing the Covers and Handle .........................................................................................31
Removing the MMI (Man-Machine (User) Interface) Cover ................................................31
Removing the Left and Ride Side Covers...........................................................................33
Removing the Rear Cover..................................................................................................34
Removing the Bottom Front Cover.....................................................................................35
Removing the Top Cover ...................................................................................................35
Removing the Handle ........................................................................................................36
Removing the Trolley .........................................................................................................37
Release of PCB Spacer Supports..........................................................................................39
Slide Lock Connector ............................................................................................................39
Power Supply Transformer Assembly....................................................................................40
Removing the Power Supply Transformer Assembly .........................................................40
Power Supply Transformer Assembly Parts.......................................................................41
Controller Board ....................................................................................................................42
Controller Board Connectors..............................................................................................44
Controller Board Fuses ......................................................................................................44
Controller Board Indicators ................................................................................................45
Controller Board Status......................................................................................................46
Removing the Controller Board ..........................................................................................47
Controller Board Parts........................................................................................................48
TEC (Thermo-Electric Components) Control Board...............................................................48
Removing TEC Control Board............................................................................................50
TEC Controller Parts..........................................................................................................51
Human Sensors (HS) Board ..................................................................................................52
Removing the Human Sensors Board ................................................................................53
Human Sensors Board Parts..............................................................................................54
Man-Machine (User) Interface (MMI).....................................................................................55
FP Board ...............................................................................................................................56
Removing the FP Board.....................................................................................................57
FP Board Parts ..................................................................................................................57

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Heating Cooling Unit (HCU)...................................................................................................58
Z Heat Exchanger..............................................................................................................59
Thermal Exchange Components (Peltier)...........................................................................59
Heat Sink ...........................................................................................................................59
Fan ....................................................................................................................................60
Removing the HCU ............................................................................................................60
HCU Parts..........................................................................................................................61
Pump.....................................................................................................................................61
Solenoid Bypass Valve..........................................................................................................62
Removing the Solenoid Bypass Valve................................................................................62
Solenoid Bypass Valve Parts .............................................................................................62
Thermistors ...........................................................................................................................63
Replacing the Water-out and Thermostat Thermistor.........................................................63
Replacing the Water-In Thermistor.....................................................................................64
Float ......................................................................................................................................64
Water Tank Assembly ...........................................................................................................67
Draining the Water Tank ....................................................................................................67
Removing the Water Tank .................................................................................................68
Water Tank Top Cover Assembly ......................................................................................68
Filter ......................................................................................................................................68
Replacing the Filter ............................................................................................................68
Removing the Filter............................................................................................................69
Installing the New Filter......................................................................................................69
Filter Parts .........................................................................................................................69
Pump.....................................................................................................................................70
Removing the Pump ..........................................................................................................70
Pump Parts........................................................................................................................71
Pump Block Diagram .........................................................................................................72
Pump Block Parts ..............................................................................................................72
Solenoid Bypass Valve..........................................................................................................73
Water-In and Water-Out Connectors .....................................................................................73
Removing the Water-In and Water-Out Connectors ...........................................................73
Water Connector Parts.......................................................................................................74
Self-Test on System Startup..................................................................................................75

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Safety Algorithm ....................................................................................................................75
Halt Conditions ......................................................................................................................76
Technician Mode Error Messages .........................................................................................78
Explanation of Error Messages ..........................................................................................78
Overview of the Periodic Maintenance Procedures................................................................80
Technician Mode ...................................................................................................................81
Technician Mode Screens..................................................................................................81
Entering Technician Mode..................................................................................................84
Performing Periodic Maintenance Verification Tests..............................................................85
Completing the Periodic Maintenance Form.......................................................................85
Removing the Covers.........................................................................................................85
Water Filter and Air Intake Maintenance ............................................................................86
Verifying Pump Life............................................................................................................86
Verifying Core and Surface (Human) Temperature Accuracy.............................................86
Verifying Water Temperature Sensors ...............................................................................87
Verifying the Thermostat....................................................................................................89
Verifying the Pressure........................................................................................................90
Verifying the TECs Electrical Current.................................................................................92
Verifying Fan Function .......................................................................................................95
Performing a Self-Cleaning Procedure ..................................................................................96
Required Equipment ..........................................................................................................96
Performing the Self Cleaning Procedure ............................................................................97
Checking for Water Leakage .................................................................................................98
Running the Self-Test............................................................................................................98
Leakage Current Test............................................................................................................98
Test System Organization..................................................................................................98
Halt Messages.....................................................................................................................101
Text Messages....................................................................................................................103
Calibration Tool Set: Verification and Calibration Units........................................................105
Temperature Calibration Unit (Part Number 017-00284) .....................................................106
Digital Pressure Gauge (Part Number 017-00290) ..............................................................106
Installing the Digital Pressure Gauge ...............................................................................107
TEC Verification Unit (Part Number 017-00189) ..................................................................108

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Verification and Calibration Cables (Part Numbers 300-00093 and 300-00094) ..................108
Thermostat Verification Tool (Part Number 017-00229).......................................................109
PCB Extraction Tool (Part Number 017-00236) ...................................................................109
Standard Tools....................................................................................................................110
Disclaimer ...........................................................................................................................111
CritiCool – Targeted Temperature Management..................................................................111
CritiCool Spare Parts List ....................................................................................................112
Downloading Software to a PC............................................................................................127
Downloading Software to the CritiCool Device.....................................................................127
Downloading the Color Display Panel Software...................................................................129
Instructions for Recycling.....................................................................................................132

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LIST OF FIGURES
Figure 1: Labels on CritiCool Device .........................................................................................15
Figure 2: CritiCool device: Front View .......................................................................................19
Figure 3: CritiCool device: Side View ........................................................................................20
Figure 4: CritiCool device: Rear Panel ......................................................................................21
Figure 5: Unpacking the CritiCool Device..................................................................................24
Figure 6: Assembling the Handle ..............................................................................................25
Figure 7: Packing Instructions for Transport..............................................................................28
Figure 8: Removing CritiCool Covers ........................................................................................30
Figure 9: MMI (Man-Machine (User) Interface) Cover ...............................................................31
Figure 10: J4 on Controller Board .............................................................................................32
Figure 11: Removing the Left and Right Side Covers................................................................33
Figure 12: Removing the Bottom Front Cover ...........................................................................35
Figure 13: Removing the Handle...............................................................................................36
Figure 14: Removing the Trolley ...............................................................................................37
Figure 15: Extraction Tool (From End) ......................................................................................39
Figure 16: Extraction Tool (From Side) ....................................................................................39
Figure 17: Slide Lock Connector ...............................................................................................40
Figure 18: Power Supply Transformer Assembly ......................................................................41
Figure 19: Controller Board Component Placement - Print Side................................................45
Figure 20: Controller Board Components..................................................................................46
Figure 21: Removing the Controller Board ................................................................................47
Figure 22: TEC Control Board Components..............................................................................50
Figure 23: TEC Controller Assembly .........................................................................................51
Figure 24: Human Sensors Board.............................................................................................52
Figure 25: Removing the Human Sensors Board ......................................................................54
Figure 26: CritiCool Display.......................................................................................................55
Figure 27: FP Board..................................................................................................................56
Figure 28: Removing the FP Board...........................................................................................57
Figure 29: HCU Assembly.........................................................................................................58
Figure 30: Z Heat Exchanger - Cross-section ...........................................................................59
Figure 31: Removing the HCU ..................................................................................................60
Figure 32: Removing the Solenoid Bypass Valve......................................................................62
Figure 33: Socket Location .......................................................................................................63
Figure 34: Float Electrical Connections.....................................................................................64
Figure 35: Hydraulic System .....................................................................................................66
Figure 36: Connecting Tubes and Special Male Connector.......................................................67
Figure 37: Filter.........................................................................................................................68
Figure 38: Filter Installation.......................................................................................................69
Figure 39: Removing the Pump.................................................................................................70
Figure 40: Pump Block Diagram ...............................................................................................72
Figure 41: Removing the Water-In and Water-Out Connectors .................................................73
Figure 42: Technician Mode Screen - Tab 1 .............................................................................81
Figure 43: Technician Mode Screen - Tab 2 .............................................................................83
Figure 44: Entering Technician Mode........................................................................................84

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Figure 45: Thermostat Socked on Human Sensors Board ........................................................89
Figure 46: Thermostat Verification Tool.....................................................................................90
Figure 47: FP Pressure Board...................................................................................................91
Figure 48: TEC Current Verification Unit ...................................................................................92
Figure 49: Leakage Test Equipment Connections.....................................................................99
Figure 50: Grounding Locations on Device .............................................................................100
Figure 51: Temperature Simulator FOGG TP 400 (Part Number 017-00284)..........................106
Figure 52: Digital Pressure Gauge (Part Number 017-00290) .................................................106
Figure 53: Water-Out Connection (Left) and Water-In Connection (Right)...............................107
Figure 54: Digital Pressure Gauge Connected ........................................................................107
Figure 55: TEC Verification Unit..............................................................................................108
Figure 56: Core Calibration Cable...........................................................................................108
Figure 57: Surface Calibration Cable ......................................................................................108
Figure 58: Thermostat Verification Tool...................................................................................109
Figure 59: PCB Extraction Tool...............................................................................................109
Figure 60: CritiCool Control Unit .............................................................................................111
Figure 61: Download Complete Message................................................................................128
Figure 62: CRC Number .........................................................................................................129
Figure 63: Color Display Panel Software Download ................................................................129
Figure 64: Display Loader Window..........................................................................................130

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LIST OF TABLES
Table 1: Symbols ......................................................................................................................16
Table 2: Accessories.................................................................................................................22
Table 3: 200-00300 CritiCool Adult Accessory Kit with Reusable Probes..................................26
Table 4: 200-00310 CritiCool Adult Accessory Kit for Use With Disposable Temperature Probes
.................................................................................................................................................26
Table 5: 200-00320 CritiCool Infant Accessory Kit with Reusable Probes.................................27
Table 6: 200-00330 CritiCool Infant Accessory Kit for Use With Disposable Temperature
Probes ......................................................................................................................................27
Table 7: Trolley Parts................................................................................................................37
Table 8: Power Supply Transformer Assembly Parts ................................................................41
Table 9: Controller Board - Power ON LEDs on the Controller ..................................................43
Table 10: Controller Board - Connectors...................................................................................44
Table 11: Controller Board Status .............................................................................................46
Table 12: CritiCool Controller Board Parts ................................................................................48
Table 13: TEC Control Board - Fuse List...................................................................................48
Table 14: TEC Control Board - Connectors...............................................................................49
Table 15: TEC Control Board LED Indicators............................................................................49
Table 16: TEC Controller Parts .................................................................................................51
Table 17: Human Sensors Board - Input Signals.......................................................................53
Table 18: Human Sensors Board - Connectors .........................................................................53
Table 19: Human Sensors Board Parts.....................................................................................54
Table 20: MMI CritiCool Display Part Number...........................................................................55
Table 21: FP Board Parts..........................................................................................................57
Table 22: HCU Assembly Part Number.....................................................................................58
Table 23: HCU Parts.................................................................................................................61
Table 24: Solenoid Bypass Valve Parts....................................................................................62
Table 25: Hydraulic System - Block Diagram ............................................................................66
Table 26: Filter Parts.................................................................................................................70
Table 27: Pump Parts ...............................................................................................................71
Table 28: Pump Block Parts......................................................................................................72
Table 29: Water Connector Parts..............................................................................................74
Table 30: HALT Conditions .......................................................................................................76
Table 31: Technician Mode Error Messages .............................................................................78
Table 32: Technician Mode Screen - Tab 1 Components..........................................................82
Table 33: Technician Mode Screen - Tab 2 Components..........................................................83
Table 34: Verification Form - Core and Surface Temperature Test Results...............................87
Table 35: Verification Form – Water Temperature Sensors.......................................................88
Table 36: Verification Form - Pressure......................................................................................91
Table 37: Halt Messages - System Shutdown.........................................................................101
Table 38: Text Messages........................................................................................................103
Table 39: Calibration Toolset (Part Number 017-00210) .........................................................105
Table 40: CritiCool Spare Parts List ........................................................................................112
Table 41: Recycling Information..............................................................................................133

CritiCool
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Service Manual
BELMONT MEDICAL TECHNOLOGIES
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ABOUT THIS MANUAL
This chapter provides information about the definitions used in this Service Manual, applicable
systems for service, and essential performance.
Definitions
WARNING! Indicates a condition that may endanger the patient or the system
operator.
CAUTION! Indicates a condition that may damage the equipment.
NOTE: Indicates an informational statement in which the system’s
operation can be made more efficient.
Applicable Systems
This Service Manual covers only the CritiCool
®
Targeted Temperature Management
system.
Essential Performance
The following functions are considered essential by the manufacturer:
•Water temperature control
•Unexpected core temperature alarm
WARNING! The system shuts down (halts) if any elements of the control mechanism fail.
End of Service Life Policy
Belmont Medical Technologies is committed to providing parts and service for all its
medical equipment purchased from Belmont for 7 full years from original date of
manufacture. Once equipment ages beyond its initial 7 years, it is considered
“Manufacturer Service End of Life” and is no longer serviceable by Belmont. While we
are unable to repair or supply spare parts for Manufacturer Service End of Life systems,
we will continue to provide technical support and troubleshooting consultation.

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NOTICES, WARNINGS AND PRECAUTIONS
This chapter provides important information about servicing, labeling, warnings and precautions
related to CritiCool
®
.
Intended Use
CritiCool is a thermal regulating system indicated for monitoring and controlling patient
temperature as determined by the physician.
Testing After Servicing the System
As a result of service or maintenance to CritiCool, the steps detailed in Chapter 9
PERIODIC MAINTENANCE should be performed in order to ensure that the system is
operating normally. If the system is not due for full Periodic Maintenance, the steps
related to thermal disinfection and water filter replacement may be omitted, since these
steps do not test system performance. Any failures resulting from the Periodic
Maintenance procedure should be addressed by further service. This process must be
repeated until all Periodic Maintenance steps pass. Failure to ensure a passing Periodic
Maintenance procedure before putting CritiCool back into service may result in failure
during usage.
Warnings
The following warnings are intended for the authorized Belmont Medical Technologies
representative when servicing the CritiCool system. For warnings related to patient use,
see the CritiCool User Manual.
•Do not insert wet plugs of the human temperature probes into the probe sockets
of the CritiCool device.
•Before initiating maintenance procedures, disconnect the power cord from the
power source.
•The repair, calibration, and servicing of the CritiCool system should be performed
only by Belmont Medical Technologies or authorized agents trained by Belmont
Medical Technologies.

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Precautions
Follow the warnings and cautions listed in this manual. The following precautions are
intended for the authorized Belmont Medical Technologies representative for servicing
the CritiCool device. For warnings and precautions related to patient use, see the
CritiCool User Manual.
•The repair and servicing of the CritiCool device should be performed only by
medical equipment service technicians trained and certified by Belmont
Medical Technologies or authorized agents of Belmont Medical Technologies.
•If moisture or leaks are discovered in the connecting hose and/or wrap, turn
off the CritiCool device, disconnect the power cable from its power source,
and correct the problem before proceeding.
•If the device sounds an alarm and/or presents a display other than the
standard Belmont Medical Technologies display, the operator should proceed
according to the display message and/or the troubleshooting instructions. For
details, see Chapter 10.
•Do not block the CritiCool device ventilation grilles. Air must be able to flow
freely in and out in order to keep the device cool.
•Do not use de-ionized or distilled water or water created through reverse
osmosis because it may promote corrosion of the metal components of the
system. Use sterile water or 0.22 µ filtered water only.

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EMC Safety
For safe use of the CritiCool
®
system, it is required to keep the CritiCool system at a safe
distance from devices emitting radio frequency (RF).
Improper Use
WARNING! Improper use of the CritiCool system can lead to skin lesions, electrical
hazards, and severe changes in body temperature.
CAUTION! U.S. Federal law restricts this device to sale to or on the order of a
physician.
Equipment Disposal and Recycling
For details on equipment disposal and recycling, see Chapter 16.

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Figure 1: Labels on CritiCool Device
Labels
This section provides details about the labels and symbols located on the exterior of the
CritiCool device.
CritiCool Device Labels
Figure 1 shows the label and its location on the CritiCool device.

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Symbols
Table 1 lists and describes the symbols that appear on the label.
Table 1: Symbols
Symbol Description
CE mark of conformity
AC Voltage
Fuse
The serial number for this product
Catalogue number
European Authorized Representative
Switzerland Authorized Representative
Caution
Type BF equipment
Recycle for WEEE
Date of manufacture

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Symbol Description
Name of manufacturer
Do not push
Refer to instruction manual
Prescription use only

CritiCool
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Service Manual
BELMONT MEDICAL TECHNOLOGIES
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SYSTEM DESCRIPTION
This chapter describes the major components of the CritiCool system.
CritiCool
®System
The CritiCool system is composed of two elements:
•CritiCool device
The CritiCool device functions as a control unit and a cooling/heating pump which
circulates water to a connected wrap applied to the patient called CureWrap
®
.
The control unit constantly monitors the patient’s core temperature through
specific sensors using a software driven temperature control algorithm to reach
the desired set point temperature. The cooling/heating pump brings the water to
the required temperature and the pump circulates it through the specially
designed wrap that is worn by the patient.
Timed pauses of flow during clinical operation regulate the water pressure and
water flow in CureWrap. During the initial phase of regulation, the flow cycle is 12
minutes ON (water flows through the wrap) and 1 minute OFF (water recirculates
within CritiCool; no flow through the wrap) in both TTM and Normothermia
modes.
In a steady state (when the Core Temperature is within the Set Point range), the
cycle is 12 minutes ON and 12 minutes OFF.
CritiCool is equipped with a handle and wheels for transport.
•CureWrap
®
CureWrap is a single-use flexible 3D single piece fabric design, through which
the water circulates. It is designed to be in close contact with a large area of the
body, thus allowing optimization of energy transfer.

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External Features
This section provides images of the front view, side view, and rear panel of the CritiCool
®
device.
Front View
Figure 2 shows the front view of the CritiCool device with callouts of key components.
Figure 2: CritiCool device: Front View

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Side View
Figure 3 shows the side view of the CritiCool
®
device with callouts of key components.
Rear Panel
Figure 4 shows the rear panel of the CritiCool
®
device with callouts of key components.
Figure 3: CritiCool device: Side View