Belmont Medical Technologies CritiCool User manual

DDT-136-000 Rev. E English
CritiCool
®
User Manual

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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
Copyright by Belmont Medical Technologies. All RIGHTS RESERVED
Registered trademarks are the intellectual property of their respective holders.

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Use of Manual
The purpose of this manual is to help medical personnel trained on the usage of
this system understand and operate the system. It is important that you read this
manual and familiarize yourself thoroughly with its contents before you attempt to
operate the system. If you do not understand any part of this manual, or if
anything is unclear or ambiguous in any way, please contact your Belmont
Medical Technologies representative.
The CritiCool
®
system described in this manual has been designed to meet
international safety and performance standards. Only trained medical personnel
may operate the system, and these operators must first have a full understanding
of the proper operation of the system.
The information provided in this manual is not intended to replace regular medical
training procedures.
This manual should always accompany the system. All qualified personnel
operating the system should know the location of the manual. For additional copies
of this manual, please contact your Belmont Medical Technologies representative.
Training
Belmont Medical Technologies or its authorized distributor will provide training for
the system user according to the intended use of the system.
It is the responsibility of the hospital management to ensure that only users
trained to use the equipment safely operate the system.
Operator Profile
Connections and system settings should be performed by a clinical expert in
thermoregulation.

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Important Notice
No part of this manual may be reproduced or copied in any form by any graphic,
electronic or mechanical means - including photocopying, scanning, typing or
information retrieval systems - without advanced written permission from Belmont
Medical Technologies.
Disclaimer
NOTE: Instructions regarding the reusable temperature probes are
NOT applicable for the US market.
Belmont Medical Technologies is not responsible for any consequential or
incidental damages or expenses of any kind, impairment of or damage to other
goods caused by the following:
a. Installed, operated, maintained contrary to Belmont Medical
Technologies instructions, notes or warnings under this manual.
b. Ignoring any of the warnings, precautions and safety measures indicated in
this manual.
c. Replacement, repair or alteration not performed by Belmont Medical Technologies or
authorized personnel.
d. The use of accessories and other parts or equipment made by other
manufacturers, whether or not warranted by such manufacturers, which have
been attached or connected to the system after installation, unless such
accessories and other parts have been supplied and attached or installed by
Belmont Medical Technologies.
e. Using the system in a contrary manner than indicated in this manual or using
the system for any purpose other than indicated in the manual.

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TABLE OF CONTENTS
CHAPTER 1: SAFETY PRECAUTIONS .............................................................................................11
Definitions...........................................................................................................................................11
Intended Use ......................................................................................................................................11
Contraindications................................................................................................................................11
Warnings ............................................................................................................................................11
Precautions.........................................................................................................................................12
EMC Safety ........................................................................................................................................13
Improper Use......................................................................................................................................13
Labels.................................................................................................................................................14
Label Symbols ....................................................................................................................................15
CHAPTER 2: SYSTEM DESCRIPTION..............................................................................................17
General Description ............................................................................................................................17
CritiCool
®
System ...............................................................................................................................18
CritiCool
®
Device ................................................................................................................................18
External Features ...............................................................................................................................19
Front View ..........................................................................................................................................19
Side View............................................................................................................................................20
Rear Panel..........................................................................................................................................21
CureWrap
®
.........................................................................................................................................22
Description and Intended Use.............................................................................................................22
Wrap Material .....................................................................................................................................22
Usage Duration...................................................................................................................................22
Selected Wrap Design ........................................................................................................................24
Accessories ........................................................................................................................................24
Temperature Probes...........................................................................................................................24
Detachable Electric Power Cable & Plug ............................................................................................27
Connecting Tubes for Wrap ................................................................................................................27
Male Connector for Draining Water Tank............................................................................................27
Spare Water Filter...............................................................................................................................27
Handle ................................................................................................................................................27
CliniLogger™ (Optional) .....................................................................................................................27
Temperature Splitter (Optional)...........................................................................................................28
System Specifications.........................................................................................................................28
CritiCool
®
Technical Specifications .....................................................................................................29
CliniLogger™ Technical Specifications ...............................................................................................31
CHAPTER 3: INSTALLATION ............................................................................................................32
Pre-installation Requirements.............................................................................................................32
Space and Environmental Requirements............................................................................................32
Electrical Requirements......................................................................................................................32
Equipment List....................................................................................................................................32
Unpacking and Inspection...................................................................................................................33

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Unpacking CritiCool from the Box .......................................................................................................33
Assembling the Handle.......................................................................................................................34
Moving the Unit...................................................................................................................................35
Preparation: ........................................................................................................................................35
Locking and Unlocking the Trolley Wheels..........................................................................................35
Packing CritiCool for Shipment ...........................................................................................................35
CHAPTER 4: OPERATING INSTRUCTIONS .....................................................................................36
General...............................................................................................................................................36
CritiCool Functions .............................................................................................................................37
Controls, Functions, Indicators and Connections ................................................................................38
Main Power Switch .............................................................................................................................38
CritiCool
®
Screen Controls..................................................................................................................38
QCC— Quick Coupling Connectors....................................................................................................39
Temperature Probe Sockets ...............................................................................................................40
Patient Thermoregulation – Step by Step Operation ...........................................................................40
Operating the System .........................................................................................................................40
Inserting and Attaching Temperature probes ......................................................................................42
Connecting the Water Hoses (Tubes) to CritiCool...............................................................................43
Activating the System .........................................................................................................................44
Wrapping the Patient ..........................................................................................................................45
The Control Panel...............................................................................................................................45
Patient Mode ......................................................................................................................................46
The Main Menu...................................................................................................................................50
Standby Mode ....................................................................................................................................51
Mode Select........................................................................................................................................52
Temperature Graph ............................................................................................................................54
Settings ...............................................................................................................................................55
Services ..............................................................................................................................................58
Modes of Operation ............................................................................................................................60
Normothermia Management ...............................................................................................................67
Replacing the Wrap ............................................................................................................................70
Operation Panel Messages and Alerts................................................................................................71
Safety Messages and Alarms .............................................................................................................72
Clinical Messages and Alarms ............................................................................................................73
Technical Messages ...........................................................................................................................75
Informative Messages.........................................................................................................................78
TTM Mode Messages .........................................................................................................................79
Controlled Rewarming Mode Messages .............................................................................................82
CHAPTER 5: ORDERING INFORMATION.........................................................................................84
Equipment and Accessories................................................................................................................84
Available Wraps..................................................................................................................................84
Available Accessories.........................................................................................................................85
CHAPTER 6: MAINTENANCE............................................................................................................87
Introduction.........................................................................................................................................87
Service Information.............................................................................................................................87
Routine Maintenance..........................................................................................................................88

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Routine Maintenance Overview ..........................................................................................................89
Before Each Use.................................................................................................................................89
Before Storage ...................................................................................................................................90
Thermal Disinfection (Self-Cleaning)...................................................................................................91
System Check Service........................................................................................................................91
Filter Replacement..............................................................................................................................93
CHAPTER 7: TROUBLESHOOTING ..................................................................................................94
General...............................................................................................................................................94
Troubleshooting Guide........................................................................................................................94
CHAPTER 8: CLINILOGGER™ INSTALLATION AND OPERATING INSTRUCTIONS ....................103
Overview and Installation..................................................................................................................103
Introduction.......................................................................................................................................103
Using the CliniLogger
™
Application ...................................................................................................103
The CliniLogger
™
Software ...............................................................................................................103
Installing the Software.......................................................................................................................103
Using the CliniLogger
™
Viewer Application .......................................................................................107
Downloading Data ............................................................................................................................107
Viewing Downloaded Data................................................................................................................108
CliniLogger
™
Viewing Panel..............................................................................................................110
Converting to Excel...........................................................................................................................117
Ending a Viewing Session ................................................................................................................118
APPENDIX A: ...................................................................................................................................119
Belmont Medical Technologies CUSTOMER SERVICE REPRESENTATIVE...................................119
APPENDIX B: RF SEPARATION......................................................................................................120
APPENDIX C: WASTE ELECTRICAL & ELECTRONIC EQUIPMENT (WEEE)................................121

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LIST OF FIGURES
Figure 1: Label Placement for the CritiCool
®
Device. ........................................................................... 14
Figure 2: Front View............................................................................................................................. 19
Figure 3: Side View.............................................................................................................................. 20
Figure 4: Rear View. ............................................................................................................................ 21
Figure 5: Measurements. ..................................................................................................................... 23
Figure 6: Disposable Temperature Probe Connections........................................................................ 26
Figure 7: Handle Assembly. ................................................................................................................. 34
Figure 8: Self-Test Screen. .................................................................................................................. 40
Figure 9: Mode Select Upon Startup .................................................................................................... 44
Figure 10: Main Screen........................................................................................................................ 44
Figure 11: The Control Panel. .............................................................................................................. 45
Figure 12: Main Menu. ......................................................................................................................... 50
Figure 13: Standby Mode..................................................................................................................... 51
Figure 14: Select Mode Panel.............................................................................................................. 52
Figure 15: Temperature Graph............................................................................................................. 54
Figure 16: Settings Screen 1................................................................................................................ 55
Figure 17: Settings Screen 2................................................................................................................ 56
Figure 18: Settings Screen 3................................................................................................................ 56
Figure 19: Settings Screen 4................................................................................................................ 57
Figure 20: Start Emptying Panel. ......................................................................................................... 59
Figure 21: Emptying Water - Performing Panel. ................................................................................... 59
Figure 22: Core Readout Too Low Message........................................................................................ 61
Figure 23: Thermoregulation is Continuing Message ........................................................................... 62
Figure 24: Select Mode Controlled Rewarming. ................................................................................... 63
Figure 25: Switching to Rewarming Message. ..................................................................................... 64
Figure 26: Controlled Rewarming Mode............................................................................................... 64
Figure 27: Temperature Regulation Paused Message ......................................................................... 65
Figure 28: Target Temperature Setting Panel ...................................................................................... 66
Figure 29: Normothermia Mode ........................................................................................................... 68
Figure 30: Out of Normothermia Message ........................................................................................... 69
Figure 31: Adjustable Alarm Limits....................................................................................................... 71
Figure 32: Low Core Temperature Message. ....................................................................................... 79
Figure 33: Temperature Regulation Paused Message. ........................................................................ 80
Figure 34: Thermoregulation is Continuing Message. .......................................................................... 81
Figure 35: Core Readout too Low Message. ........................................................................................ 82
Figure 36: Thermoregulation is Continuing Message. .......................................................................... 83
Figure 37: Selecting System Check. .................................................................................................... 92
Figure 38: System Check in Progress.................................................................................................. 92
Figure 39: CliniLogger™ Initialization................................................................................................. 104
Figure 40: CliniLogger™ Installation. ................................................................................................. 104
Figure 41: Start Installation. ............................................................................................................... 105
Figure 42: Installation Progress.......................................................................................................... 105
Figure 43: Installation Complete......................................................................................................... 106
Figure 44: CliniLogger™ Application Window. ................................................................................... 107
Figure 45: CliniLogger™ Window....................................................................................................... 108
Figure 46: Choose CliniLogger™ File Window................................................................................... 109
Figure 47: Complete Message. .......................................................................................................... 109

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Figure 48: CliniLogger™ Viewing Panel............................................................................................. 110
Figure 49: Graphic Display Area. ....................................................................................................... 111
Figure 50: Example: Functional Status Area. ..................................................................................... 112
Figure 51: Example: Modes and Errors Area. .................................................................................... 112
Figure 52: Example of Modes and Error Area. ................................................................................... 116
Figure 53: Section of Excel Table. ..................................................................................................... 117
Figure 54: Section of Graphic Chart................................................................................................... 118

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LIST OF TABLES
Table 1: Key to Label Symbols ............................................................................................................ 15
Table 2: CureWrap
®
............................................................................................................................. 24
Table 3: Disposable Temperature Probes............................................................................................ 27
Table 4: CritiCool
®
screen keys............................................................................................................ 38
Table 5: Clinical Messages .................................................................................................................. 73
Table 6: Clinical Messages .................................................................................................................. 74
Table 7: Technical Messages and Alarms............................................................................................ 75
Table 8: Technical Messages and Alarms............................................................................................ 76
Table 9: Technical Messages and Alarms............................................................................................ 77
Table 10: Wrap Information.................................................................................................................. 84
Table 11: CritiCool Infant Reusable Accessory Kit (PN# 200-00320) ................................................... 85
Table 12: CritiCool Adult Reusable Accessory Kit (PN# 200-00300).................................................... 85
Table 13: CritiCool Infant Disposable Accessory Kit (PN# 200-00330)................................................. 86
Table 14: CritiCool Adult Disposable Accessory Kit (PN# 200-00310) ................................................. 86
Table 15: Accessories.......................................................................................................................... 86
Table 16: Inspection and Maintenance Schedule................................................................................. 88
Table 17: CritiCool
®
System Malfunction (no message) Troubleshooting Guide................................... 95
Table 18: Water Tank Overfilling.......................................................................................................... 96
Table 19: CritiCool® System Messages Troubleshooting Guide .......................................................... 97
Table 20: CritiCool® System Messages Troubleshooting Guide .......................................................... 98
Table 21: CritiCool® System Messages Troubleshooting Guide .......................................................... 99
Table 22: CritiCool® System Messages Troubleshooting Guide ........................................................ 100
Table 23: CritiCool® System Messages Troubleshooting Guide ........................................................ 101
Table 24: Zoom Tool Buttons............................................................................................................. 114
Table 25: Mode Codes....................................................................................................................... 116
Table 26: Separation Distances in meters.......................................................................................... 120

Chapter 1: Safety Precautions
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C HAPTER 1: S AFETY P RECAUTIONS
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 ways in which the system’s operation can be made more efficient.
Intended Use
CritiCool
®
is a thermal regulating system, indicated for monitoring and controlling
patient temperature.
Contraindications
CritiCool
®
should not be used on patients with open wounds.
Warnings
1. The physician must be notified if the patient's temperature does not
respond properly, does not reach the prescribed temperature, or if there is
any change in the prescribed temperature range. Failure to inform the
physician may result in injury to the patient.
2. The misuse of the temperature regulation equipment can be potentially
harmful to the patient.
3. Use only sterile water or 0.22 μm filtered water. Sterile water is
recommended.
4. Do not plug wet probes into the sockets of theCritiCool
®
device.
5. The user should verify that no fluids are present at the skin/wrap interface
during the procedure. Failure to do so can cause lesions on the patient's
skin.
6. Following the procedure, a pattern resembling the wrap may appear for a
short period of time on the patient's skin.
7. Pressure sores may appear or develop when soft tissue is compressed
between a bony prominence and external surface. The use of the CritiCool
®
system does not prevent this from happening.

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8. Routine care should be taken during long thermoregulation procedures to
prevent pressure sores.
9. Do not lift or move the patient by means of the wrap. This may cause tearing
and water leakage.
10. Prevent any thermal isolation, such as a pillow or other items, between
the Wrap and the patient's body.
11. Do not apply heating/cooling to lower extremities during aortic cross
clamping. Thermal injury may occur if heating/cooling is applied to
ischemic limbs.
12. Wraps cannot be placed over transdermal patches.
13. Wraps should not come in contact with open wounds.
14. CureWrap
®
should not be in direct contact with open, widespread skin
lesions such as burns or dermatitis.
15. Caution should be taken when using CureWrap
®
with patients that have
underlying skin conditions.
16. Do not touch the ribbon cable behind the display and the patient
simultaneously.
17. Patients thermoregulated with CritiCool
®
should be closely monitored at all
times.
Precautions
1. Follow the warning notes listed in the various sections of this manual.
2. Only trained personnel, familiar with all system operating procedures and
certified only by Belmont Medical Technologies or authorized agents of
Belmont Medical Technologies are allowed to use the CritiCool
®
system.
3. 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.
4. If the system 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 ( see “Troubleshooting Guide”).
5. Avoid folds in the Wrap—these may obstruct water flow.
6. Do not block the CritiCool
®
system ventilation grilles. Air must be able to
flow freely in and out in order to keep the system cool.
7. Do not use de-ionized water or water created through reverse osmosis
because it may promote corrosion of the metal components of the system.
8. When X-ray imaging is performed on a patient wearing a wrap, shadows from
the wrap may appear on the X-ray film. Connecting water hoses should not
be connected to the patient during imaging as they contain metal.

Chapter 1: Safety Precautions
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9. Avoid inserting any sharp object between the patient and the Wrap.
10. Read all manufacturers’ instructions associated with the temperature probes
or temperature probe adapters supplied by Belmont Medical Technologies.
11. Accessories from one system should not be moved or switched out with those from
another system to avoid cross-contamination.
EMC Safety
For safe use of the CritiCool
®
, it is required to keep the CritiCool
®
at a safe
distance from systems emitting radio frequency (RF) energy.
Refer to Appendix B for recommended separation distances between the
CritiCool
®
and RF source.
CAUTION!
Power interruptions shorter than 10 minutes return the machine to the mode that
was operating before the interruption with a 3-beep alarm.
IMPORTANT! Make sure to read the messages to ensure correct
reactivation of the machine.
Improper Use
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 system to sale by or on the order
of a physician.

Chapter 1: Safety Precautions
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Figure 1: Label Placement for the CritiCool
®
Device.
Labels
CritiCool®System Labels

Chapter 1: Safety Precautions
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Label Symbols
Table 1: Key to Label Symbols
Description
Symbol
CE mark of conformity indicates that the product
has received the European approval for MDD
93/42/EEC.
AC Voltage
Fuse
The serial number for this product
Catalogue part number
European Authorized Representative
Switzerland Authorized Representative
Caution – refer to user manual
Type BF equipment
Recycle for WEEE
Date of manufacture
XX/XX/XXXX

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Name of manufacturer
Country of manufacturer
Do not push
Refer to instruction manual / booklet
Restricts the sale and use of this instrument to
qualified medical personnel only.
Unique Device Identifier
Instructions for Use
Does not contain natural rubber latex
Medical Device
Do Not Reuse

Chapter 2: System Description
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CHAPTER 2: SYSTEM DESCRIPTION
General Description
A growing number of cases require a solution for controlling patient temperature in
various hospital settings. Therapeutic hypothermia, Targeted Temperature
Management (TTM) or simply controlling normothermia is beneficial and
sometimes vital.
The CritiCool
®
system controls and maintains temperature in an effective and
precise manner. The desired temperature is preset by the physician with a
possible range of target temperatures from Hypothermia to Normothermia.
The system is composed of two elements, the CritiCool
®
device, and the
CureWrap
®
. The CritiCool
®
device functions as a control unit and a
cooling/heating pump, which circulates water. The control unit constantly
monitors the patient’s core temperature through specific probes and using its on-
board body temperature control algorithm at 133 millisecond intervals, delivers
the optimum water temperature 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 flexible and single piece CureWrap
®
.
The CureWrap
®
is designed to be in close contact with a large area of the body,
thus allowing optimization of energy transfer.
WARNING!!! The Belmont Medical Technologies wrap is proprietary to
Belmont Medical Technologies and this is the only wrap
authorized to be used with the CritiCool
®
system. Use of any
other wrap with the system may harm the patient.

Chapter 2: System Description
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CritiCool®System
The CritiCool
®
system consists of the following elements:
•CritiCool
®
device
•CureWrap
®
•Accessories
CritiCool
®Device
The CritiCool
®
device has a microprocessor that controls the water
temperature flowing into the wrap worn by the patient.
The water temperature is controlled and maintained to the desired set point
by measuring the actual patient temperature (core and surface) and adjusting
the temperature of the wrap accordingly.
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.
If the difference between the patient’s core temperature and the set point
temperature exceeds 0.3°C at any time during a timed pause, water will return to
the wrap to adjust the patient’s temperature.
The CritiCool
®
device is equipped with a handle for easy transport.

Chapter 2: System Description
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External Features
Front View
Figure 2: Front View.

Chapter 2: System Description
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Side View
Figure 3: Side View.