Belmont CritiCool MINI User manual

CritiCool®MINI
User Manual
English DDT-320-000 Rev G.

DDT-320-000 Rev G Belmont Medical Technologies Page 2of 114
Conformity according to the Council Directive 93/42/EEC as amended by 2007/47/EC
US Representative:
Belmont Medical Technologies
780 Boston Road
Billerica, MA 01821 USA
Phone [phone]
Fax [phone]
www.belmontmedtech.com
European Representative :
Emergo Europe BV
Prinsessegracht 20
2514 AP The Hague
The Netherlands
[phone]
Publication No. DDT-320-000
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 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 for further clarification.
The CritiCool
®
MINI system described in this manual has been designed
to meet international safety and performance standards. Only trained
medical personnel may operate the system. 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 device or
system.
It is the responsibility of the hospital management to ensure that only users
trained to use the equipment safely, operate the equipment.
Operator Profile
Connections and device 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: All instructions regarding the reusable temperature probes
are NOT applicable for the USA and other select markets.
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 altering not performed by Belmont Medical
Technologies’ 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
USE OF MANUAL.............................................................................................................................................................. 3
TRAINING .......................................................................................................................................................................... 3
OPERATOR PROFILE ...................................................................................................................................................... 3
IMPORTANT NOTICE ....................................................................................................................................................... 4
DISCLAIMER ..................................................................................................................................................................... 4
TABLE OF CONTENTS..................................................................................................................................................... 5
LIST OF FIGURES............................................................................................................................................................. 7
LIST OF TABLES .............................................................................................................................................................. 8
CHAPTER 1: SAFETY PRECAUTIONS ........................................................................................................................... 9
Definitions................................................................................................................................................................... 9
Intended Use .............................................................................................................................................................. 9
Warnings .................................................................................................................................................................... 9
Precautions............................................................................................................................................................... 10
EMC Safety .............................................................................................................................................................. 11
Improper Use............................................................................................................................................................ 11
Labels ....................................................................................................................................................................... 12
CHAPTER 2: SYSTEM DESCRIPTION .......................................................................................................................... 15
CritiCool® MINI System ........................................................................................................................................... 16
CritiCool
®
MINI Device ............................................................................................................................................. 16
CritiCool
®
MINI Battery ............................................................................................................................................. 16
Power Cable Connection.......................................................................................................................................... 16
Grounding the System.............................................................................................................................................. 16
Warnings .................................................................................................................................................................. 17
External Features ..................................................................................................................................................... 18
Garment/Wrap .......................................................................................................................................................... 20
Reusable Temperature Probes ................................................................................................................................ 22
Disposable Temperature Probes .............................................................................................................................. 23
System Specifications .............................................................................................................................................. 24
CHAPTER 3: INSTALLATION......................................................................................................................................... 28
Pre-installation Requirements .................................................................................................................................. 28
CHAPTER 4: OPERATING INSTRUCTIONS ................................................................................................................. 30
CritiCool
®
MINI Functions......................................................................................................................................... 30
Controls, Functions, Indicators and Connections..................................................................................................... 31
Patient Thermoregulation – Step by Step Operation ............................................................................................... 34
Services.................................................................................................................................................................... 56
Empty ....................................................................................................................................................................... 57
Replacing the Wrap .................................................................................................................................................. 58
Operation Panel Messages and Alerts..................................................................................................................... 59
Safety Messages and Alarms................................................................................................................................... 60
Clinical Messages and Alarms ................................................................................................................................. 61
Technical Messages and Alerts ............................................................................................................................... 63
Controlled Rewarming Mode Messages .................................................................................................................. 71
CHAPTER 5: ORDERING INFORMATION..................................................................................................................... 73
Equipment and Accessories..................................................................................................................................... 73
Available Wraps........................................................................................................................................................ 73
Available Accessories .............................................................................................................................................. 74
CHAPTER 6: MAINTENANCE ........................................................................................................................................ 76

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Introduction............................................................................................................................................................... 76
Service Information................................................................................................................................................... 76
Routine Maintenance ............................................................................................................................................... 77
Routine Maintenance ............................................................................................................................................... 77
Recommended Disinfectants for External Surfaces................................................................................................. 78
Cleaning, Disinfecting and Sterilization of the Reusable Temperature Probes ....................................................... 81
System Check Service ............................................................................................................................................. 82
Filter Replacement ................................................................................................................................................... 84
CHAPTER 7: TROUBLESHOOTING .............................................................................................................................. 85
General..................................................................................................................................................................... 85
Troubleshooting Guide ............................................................................................................................................. 85
CHAPTER 8: CLINILOGGER™ INSTALLATION AND OPERATING INSTRUCTIONS ............................................... 93
Overview and Installation ......................................................................................................................................... 93
Using the CliniLogger
™
Viewer Application .............................................................................................................. 97
Viewing Downloaded Data ....................................................................................................................................... 98
CliniLogger
™
Viewing Panel ................................................................................................................................... 101
Graphic Display Area.............................................................................................................................................. 102
Function Selection Area ......................................................................................................................................... 103
APPENDIX A: BELMONT MEDICAL TECHNOLOGIES CUSTOMER SERVICE ....................................................... 110
APPENDIX B: RF SEPARATION.................................................................................................................................. 111
APPENDIX C: DECLARATIONS OF COMPLIANCE ................................................................................................... 112
APPENDIX D: WASTE ELECTRICAL & ELECTRONIC EQUIPMENT (WEEE) ......................................................... 114

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LIST OF FIGURES
Figure 1: Label Placement for the CritiCool® MINI Device...........................................................................12
Figure 2: Front View.....................................................................................................................................18
Figure 3: Rear View .....................................................................................................................................19
Figure 4: Disposable Temperature Probes Connection................................................................................23
Figure 5: Self-Test Screen ...........................................................................................................................35
Figure 6: Select Mode Upon Startup ............................................................................................................38
Figure 7: Main Screen..................................................................................................................................38
Figure 8: Control Panel ................................................................................................................................39
Figure 9: Main Menu....................................................................................................................................41
Figure 10: Standby.......................................................................................................................................42
Figure 11: Select Mode Panel......................................................................................................................43
Figure 12: TTM Mode ..................................................................................................................................44
Figure 13: Selecting a Rewarming Step.......................................................................................................45
Figure 14: Rewarming Step on the Main Screen..........................................................................................46
Figure 15: Select Mode - Controlled Warming..............................................................................................47
Figure 16: Switching to Rewarming Mode....................................................................................................47
Figure 17: Low Core Temperature ...............................................................................................................48
Figure 18: Temperature Regulation Paused Message .................................................................................48
Figure 19: Out of Normothermia Message ...................................................................................................50
Figure 20: Settings Screen 1........................................................................................................................51
Figure 21: Settings Screen 2........................................................................................................................52
Figure 22: Settings Screen 3........................................................................................................................52
Figure 23: Settings Screen 4........................................................................................................................53
Figure 24: Main Panel with System ID .........................................................................................................53
Figure 25: Set-Point Setting Screen.............................................................................................................54
Figure 26: Graphic Parameters Display .......................................................................................................55
Figure 27: Select Service.............................................................................................................................56
Figure 28: Start Emptying Panel ..................................................................................................................57
Figure 29: Emptying Water-Performing Panel ..............................................................................................58
Figure 30: Adjustable Alarm Limits...............................................................................................................59
Figure 31: Low Core Temperature Alarm .....................................................................................................68
Figure 32: Temperature Regulation Paused – Core Readout Too Low Message........................................69
Figure 33: Thermoregulation is Continuing Message ...................................................................................70
Figure 34: Low Core Temperature Alarm .....................................................................................................71
Figure 35: Core Readout too Low Message.................................................................................................71
Figure 36: Thermoregulation is Continuing Message ...................................................................................72
Figure 37: Selecting Thermal Disinfection Service .......................................................................................80
Figure 38: Initiating Thermal Disinfection .....................................................................................................80
Figure 39: Thermal Disinfection Mode..........................................................................................................81
Figure 40: Selecting System Check .............................................................................................................82
Figure 41: System Check in Progress..........................................................................................................83
Figure 42: CritiCool MINI System Malfunction (No Message) Troubleshooting Guide ..................................86
Figure 43: Water Tank Overfilling.................................................................................................................87
Figure 44: CritiCool MINI System Message Troubleshooting Guide.............................................................88
Figure 45: CritiCool MINI System Message Troubleshooting Guide.............................................................89
Figure 46: CritiCool MINI System Message Troubleshooting Guide.............................................................90
Figure 47: CritiCool MINI System Message Troubleshooting Guide.............................................................91
Figure 48: CritiCool MINI System Message Troubleshooting Guide.............................................................92

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LIST OF TABLES
Table 1: Labels and Symbols.......................................................................................................................13
Table 2: CureWraps.....................................................................................................................................21
Table 3: Disposable Temperature Probes....................................................................................................24
Table 4: CritiCool® MINI screen keys ..........................................................................................................31
Table 5: Clinical Messages ..........................................................................................................................61
Table 6: Technical Messages and Alarms....................................................................................................63
Table 7: Wrap Ordering Information.............................................................................................................73
Table 8: CritiCool MINI Accessory Kit with Reusable Probes .......................................................................74
Table 9: CritiCool MINI Accessory Kit for Disposable Probes.......................................................................74
Table 10: Accessories..................................................................................................................................75
Table 11: Recommended Routine Inspection and Maintenance Schedule...................................................77
Table 12: Separation Distances in Meters..................................................................................................111
Table 13: Electromagnetic Emissions – for all ME Equipment and ME Systems ........................................113

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CHAPTER 1: SAFETY PRECAUTIONS
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
®
MINI is a thermal regulating system, indicated for monitoring
and controlling patient temperature.
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 clinician may result in injury to the patient.
2. The misuse of the temperature regulation equipment can be
potentially harmful to the patient.
3. Do not plug wet probes into the sockets of the CritiCool
®
MINI device.
4. 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.
• Following use, a pattern resembling the Wrap may appear for
a short period of time on the patient's skin.
5. Pressure sores may appear or develop when soft tissue is compressed
between a bony prominence and external surface. The use of the
CritiCool
®
MINI system does not prevent this from happening.
6. Routine care should be taken during long thermoregulation
procedures to prevent pressure sores.
7. Do not lift or move the patient by means of the Wrap. This may
cause tearing and water leakage.
8. Prevent any thermal isolation, such as a pillow or other items,
between the Wrap and the patient's body.
9. Do not apply heating/cooling to lower extremities during aortic cross

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clamping. Thermal injury may occur if heating/cooling is applied to ischemic
limbs.
10. Wraps cannot be placed over transdermal patches.
11. Wraps should not come in contact with open wounds.
12. Do not touch the ribbon cable behind the display and the patient
simultaneously.
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
®
MINI system.
3. If moisture or leaks are discovered in the connecting hose and/or
wrap, turn off the CritiCool
®
MINI device, disconnect the power cable
from its power source, and correct the problem before proceeding.
4. 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 (See CHAPTER 7: TROUBLESHOOTING).
5. Avoid folds in the Wrap—these may obstruct water flow.
6. Do not block the CritiCool
®
MINI device ventilation grilles. Air must be
able to flow freely in and out to keep the device cool.
7. Use sterile or 0.22 µm filtered water. 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.
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.

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EMC Safety
For safe use of the CritiCool
®
MINI, it is required to keep CritiCool
®
MINI at
a safe distance from devices emitting radio frequency (RF).
Refer to Appendix B for recommended separation distances between the
CritiCool
®
MINI and the RF source.
Improper Use
Improper use of the CritiCool
®
MINI system can lead to skin lesions,
electrical hazards, and severe changes in body temperature.

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Labels
CritiCool®MINI Device Labels
Figure 1: Label Placement for the CritiCool® MINI Device

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Label Symbols
Table 1: Labels and Symbols
Symbol Description
CE mark of conformity
AC Voltage
Fuse
The serial number for this product
Catalogue number
European Authorized Representative
Caution – refer to user manual
Type BF equipment
Recycle for WEEE
YYYY-MM-DD
Date of manufacture

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Manufacturer name
Refer to Instruction manual / booklet
Restricts the sale and use of this instrument to qualified medical
personnel only.

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CHAPTER 2: SYSTEM DESCRIPTION
CritiCool
®
MINI is a thermal regulating system, indicated for monitoring
and controlling patient temperature.
CritiCool
®
MINI is based on the CritiCool
®
system and offers additional
benefits with its reduced footprint and mobility.
The CritiCool
®
MINI system controls Targeted Temperature Management
(TTM) 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
®
MINI device, and
the wrap. The CritiCool
®
MINI device functions as a control unit and a
cooling/heating pump, which circulates water. The control unit monitors
the patient’s core temperature through specific probes, and using its on-
board body temperature control algorithm, delivers water 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 CureWrap™.
The CureWrap™ is a flexible 3D single piece 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.
NOTE: The Belmont Medical Technologies wrap is proprietary to
Belmont Medical Technologies and this is theonly wrap
authorized to be used with this Thermoregulation Device.

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CritiCool® MINI System
The CritiCool
®
MINI system consists of the following elements:
•CritiCool
®
MINI device
•CureWrap™
•Accessories
CritiCool
®
MINI Device
The CritiCool
®
MINI 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.
Water flow in the wrap is regulated by timed pauses of the flow during
clinical operation.
In TTM and Normothermia modes, during the initial phase of regulation,
the flow cycle is 12 minutes ON and 1 minute OFF.
In steady state (when the Core Temp is within the Set Point range), the
cycle is 12 minutes ON and 12 minutes OFF.
CritiCool
®
MINI Battery
CritiCool
®
MINI is equipped with a rechargeable lithium-ion battery which
allows the system to work without an external power supply for up to 60
minutes. The battery is shipped with a 30% charge and will need to be fully
charged before the first use.
Power Cable Connection
Connect the power cable to a hospital-grade power outlet.
Grounding the System
To protect the patient and hospital personnel, the CritiCool
®
MINI system
must be grounded. Accordingly, the system is equipped with a detachable
3-wire cable which grounds the instrument to the power line ground
(protective earth) when plugged into an appropriate 3-prong receptacle.
WARNING!!! Do not use a 3-to-2-wire adapter with this instrument.

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Warnings
Charging should be performed in a fire-safe area, away from
flammable surroundings.
Charging should be performed in an environment temperature of
between4°C and 30°C (39.2°F - 86°F).
Use only the Belmont Medical Technologies original power cord
supplied with the ground plug.

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External Features
Front View
Key – CritiCool MINI Front View:
1. Display Touch Screen
2. Functional Buttons
3. On/Off Button
4. Battery Indicator
5. AC Indicator
6. Speaker
7. Core Sensor Socket
8. Surface Sensor Socket
9. Core Out Temperature
10. Water-In Quick Coupling Connector
11. Water-Out Quick Coupling Connector
12. Water Level Indicator
13. Water Tank Cap
Figure 2: Front View

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Rear View
Key – CritiCool MINI Rear View:
1. Air Outlet Grille
2. Rear Side Cover
3. Fan
4. Air Inlet Grille
5. AC Power Plug
6. RS-232 Communication
Figure 3: Rear View

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Garment/Wrap
General
The wrap is a one-piece covering with inflow and outflow tubes that circulate
water in the wrap channels. It is designed to facilitate the wrapping of
individual parts of the body (chest, arms, thighs, etc.) to maximize surface
coverage.
Description and Intended Use
The Wrap is:
•Disposable
•Biocompatible
•Latex free
•Antistatic
•Adjustable
Each section of the Wrap is separately wrapped around the appropriate
area of the patient to ensure maximum body surface coverage. The Wrap is
intended to fit loosely. Review the CureWrap instructions for use leaflet
supplied with the wrap for further information.
The water’s exit and entrance points are short sections of tubing
integrated with a Quick Coupling Connector (QCC) and welded to
convenient locations on the edges of the Wrap.
The Wrap design allows the physician to cover a maximum surface area
as needed.
WARNING!!! The Wraps are designed for single patient use only.
Reusing may cause cross contamination and/or
irritation.
Wrap Material
•Patient Side: Non-woven Polypropylene
•Exterior: Brushed Loop Fabric
Usage Duration
•The wrap is durable for up to 5 days. Replace the wrap if it
becomes soiled.