Belmont Medical Technologies CritiCool User manual

DDT-136-000 Rev. D English
CritiCool®
User Manual
The Coolest Solution for TTM

Belmont Medical Technologies CritiCool®Operator’s Manual i
Conformity according to the Council Directive 93/42/EEC
Manufacturer’s Name
Belmont Medical Technologies
780 Boston Road
Billerica, MA 01821 USA
Technical Service
885-397-4547 (USA)
[phone] (WORLDWIDE)
www.BelmontMedTech.com
European Representative :
Copyright 2019 by Belmont Medical Technologies. All RIGHTS RESERVED
Registered trademarks are the intellectual property of their respective holders.
Emergo Europe BV
Prinsessegracht 20
2514 AP The Hague
The Netherlands
[phone]

Belmont Medical Technologies CritiCool®Operator’s Manual ii
Use of Manual
1. The purpose of this manual is to help qualified 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.
2. The CritiCool®system described in this manual has been designed to
meet international safety and performance standards. Only qualified
personnel may operate the system, and these operators must first
have a full understanding of the proper operation of the system.
3. The information provided in this manual is not intended to replace
regular medical training procedures.
4. 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 responsible of the end user to ensure that only users trained to use
the equipment efficiently and safely, operate the equipment.
Operator Profile
Connections and device settings should, typically, be performed by a
clinician expert in thermoregulation.

Belmont Medical Technologies CritiCool®Operator’s Manual iii
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.
Patent Nos. US 6,500,200 B1, US 5,508,831 B1, US 6,685,731 B1
IMPORTANT! All instructions regarding the reusable temperature
probes are NOT applicable for USA market.
Disclaimer
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 the 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.

Belmont Medical Technologies CritiCool®Operator’s Manual iv
TABLE OF CONTENTS
Use of Manual ......................................................................................................................................... ii
Training ................................................................................................................................................... ii
Operator Profile....................................................................................................................................... ii
Important Notice...................................................................................................................................... iii
Disclaimer ............................................................................................................................................... iii
Chapter 1:
Safety Precautions
Definitions ............................................................................................................................................... 1-1
Intended Use........................................................................................................................................... 1-1
Warnings................................................................................................................................................. 1-1
Precautions............................................................................................................................................. 1-2
EMC Safety .......................................................................................................................................... 1-3
Improper Use........................................................................................................................................ 1-3
Labels ..................................................................................................................................................... 1-4
CritiCool®Device Labels ...................................................................................................................... 1-4
Label Symbols...................................................................................................................................... 1-5
Chapter 2:
System Description
General Description ................................................................................................................................ 2-1
CritiCool®system ................................................................................................................................... 2-2
CritiCool®Device.................................................................................................................................. 2-2
External Features ................................................................................................................................... 2-3
Front View ............................................................................................................................................ 2-3
Side View ............................................................................................................................................. 2-4
Rear Panel ........................................................................................................................................... 2-5
Wrap..................................................................................................................................................... 2-5
Accessories .......................................................................................................................................... 2-8
System Specifications........................................................................................................................... 2-11
Chapter 3: Installation
Pre-installation Requirements................................................................................................................. 3-1
Space and Environmental Requirements............................................................................................. 3-1
Electrical Requirements ....................................................................................................................... 3-1
Unpacking and Inspection.................................................................................................................... 3-1
Assembling the Handle ........................................................................................................................ 3-2
Equipment List...................................................................................................................................... 3-2
Moving the Unit ....................................................................................................................................... 3-3
Preparation........................................................................................................................................... 3-3
Locking and Unlocking the Trolley Wheels .......................................................................................... 3-3

Belmont Medical Technologies CritiCool®Operator’s Manual vi
Chapter 4:
Operating Instructions
General.................................................................................................................................................... 4-1
Application Specification ......................................................................................................................... 4-1
Indication for Use.................................................................................................................................. 4-1
Location ................................................................................................................................................ 4-1
Patient Age and Weight........................................................................................................................ 4-1
Getting Started ........................................................................................................................................ 4-2
Turning on the System ............................................................................................................................ 4-2
Main Power Switch ............................................................................................................................... 4-2
Inserting and Attaching Temperature probes.......................................................................................... 4-4
Temperature Probes............................................................................................................................. 4-4
Wrapping the Patient............................................................................................................................... 4-5
Connecting the Tubes........................................................................................................................... 4-5
CritiCool®Screen Control Keys............................................................................................................... 4-7
The Control Panel................................................................................................................................. 4-8
Patient Mode......................................................................................................................................... 4-9
Neonatal Mode ................................................................................................................................... 4-11
Adult Mode.......................................................................................................................................... 4-11
The Main Menu ..................................................................................................................................... 4-13
Standby Mode..................................................................................................................................... 4-14
Mode Select........................................................................................................................................ 4-15
TTM (Targeted Temperature Management)....................................................................................... 4-16
Controlled Rewarming ........................................................................................................................ 4-16
Normothermia ..................................................................................................................................... 4-16
Shutting Down the Device .................................................................................................................. 4-17
Main Power Switch ............................................................................................................................. 4-17
Temperature Graph ............................................................................................................................ 4-17
Settings............................................................................................................................................... 4-18
Services .............................................................................................................................................. 4-21
Empty.................................................................................................................................................. 4-21
Modes of Operation............................................................................................................................... 4-22
Targeted Temperature Management (TTM) Mode............................................................................. 4-22
Controlled Rewarming Mode .............................................................................................................. 4-25
Controlled Rewarming Process .......................................................................................................... 4-25
Target Temperature Setting ............................................................................................................... 4-29
Manual Rewarming............................................................................................................................. 4-30
Normothermia Management ................................................................................................................. 4-30
Normothermia ..................................................................................................................................... 4-30
Exceeding the Normothermia Range ................................................................................................. 4-32
Replacing the Wrap............................................................................................................................... 4-33
Operation Panel Messages ................................................................................................................... 4-34
Technical Messages ........................................................................................................................... 4-34
Clinical Messages............................................................................................................................... 4-37
Safety Messages and Alarms ............................................................................................................. 4-39
Informative Messages......................................................................................................................... 4-40
Constant Alarms ................................................................................................................................. 4-41
TTM Mode Messages ......................................................................................................................... 4-42
Controlled Rewarming Mode Messages............................................................................................. 4-44
Chapter 5:
Ordering Information
Equipment and Accessories.................................................................................................................... 5-1
Available Wraps.................................................................................................................................... 5-1
Chapter 6:
Maintenance
Introduction ............................................................................................................................................. 6-1

Belmont Medical Technologies CritiCool®Operator’s Manual vii
Service Information................................................................................................................................. 6-1
Routine Maintenance.............................................................................................................................. 6-1
Cleaning and Disinfection ....................................................................................................................... 6-2
Routine Maintenance of External Surfaces.......................................................................................... 6-2
Required Tools for Cleaning and Disinfection...................................................................................... 6-3
Recommended Disinfectants for External Surfaces............................................................................. 6-3
Before Each Use .................................................................................................................................. 6-3
Before Storage ..................................................................................................................................... 6-4
Thermal Disinfection ............................................................................................................................... 6-5
Cautions ............................................................................................................................................... 6-5
Thermal Disinfection Process............................................................................................................... 6-6
Cleaning, Disinfecting and Sterilization of the Reusable Temperature Probes ...................................... 6-8
System Check Service............................................................................................................................ 6-8
Filter Replacement ................................................................................................................................ 6-10
Chapter 7:
Troubleshooting
General ................................................................................................................................................... 7-1
Trouble-shooting Guide .......................................................................................................................... 7-1
Chapter 8: CliniLogger™Installation and Operating Instructions
Overview and Installation........................................................................................................................ 8-1
Introduction........................................................................................................................................... 8-1
Using the CliniLogger™Application...................................................................................................... 8-1
The CliniLogger™Software .................................................................................................................. 8-1
Installing the Software .......................................................................................................................... 8-1
Using the CliniLogger™Viewer Application ............................................................................................ 8-5
Downloading Data................................................................................................................................ 8-5
Viewing Downloaded Data ................................................................................................................... 8-6
CliniLogger™Viewing Panel................................................................................................................. 8-8
Graphic Display Area ........................................................................................................................... 8-9
Function Selection Area ....................................................................................................................... 8-10
Temperature Graph Control Buttons.................................................................................................. 8-10
Display/Hide Buttons.......................................................................................................................... 8-11
Color Buttons...................................................................................................................................... 8-11
View Manipulation Buttons................................................................................................................. 8-11
Cursor Line......................................................................................................................................... 8-12
Modes and Error Area........................................................................................................................ 8-13
Functional Status Area-Heat/Cool and Pump On/Power Off ............................................................. 8-14
Converting to Excel .............................................................................................................................. 8-15
Ending a Viewing Session.................................................................................................................... 8-16
Appendix A:
Belmont Medical Technologies Customer Service Representative
Appendix B:
RF Separation

Belmont Medical Technologies CritiCool®Operator’s Manual vii
LIST OF FIGURES
Figure 1-1: Label Placement for the CritiCool®Device ..........................................................1-4
Figure 2-1: Front View ...........................................................................................................2-3
Figure 2-2: Side View.............................................................................................................2-4
Figure 2-3: Rear View ............................................................................................................2-5
Figure 2-4: Measurements.....................................................................................................2-7
Figure 2-5: Disposable Temperature Probe Connections......................................................2-10
Figure 3-1: Handle Assembly.................................................................................................3-2
Figure 4-1: Self-Test Screen ..................................................................................................4-3
Figure 4-2: Mode Select Upon Startup..................................................................................4-3
Figure 4-3: Main Screen.........................................................................................................4-4
Figure 4-4: The Control Panel................................................................................................4-8
Figure 4-5: Main Menu .......................................................................................................... 4-13
Figure 4-6: Standby Mode..................................................................................................... 4-14
Figure 4-7: Select Mode Panel...............................................................................................4-15
Figure 4-8: Temperature Graph .............................................................................................4-17
Figure 4-9: Settings Screen 1 ................................................................................................4-19
Figure 4-10: Settings Screen 2 ..............................................................................................4-19
Figure 4-11: Settings Screen 3 ..............................................................................................4-20
Figure 4-12: Settings Screen 4 ..............................................................................................4-20
Figure 4-13: Start Emptying Panel .........................................................................................4-22
Figure 4-14: Emptying Water - Performing Panel ..................................................................4-22
Figure 4-15: Core Readout too Low Message .......................................................................4-24
Figure 4-16: Thermoregulation is Continuing Message .........................................................4-25
Figure 4-17: Select Mode Controlled Rewarming ..................................................................4-27
Figure 4-18: Switching to Rewarming Message.....................................................................4-27
Figure 4-19: Controlled Rewarming Mode .............................................................................4-28
Figure 4-20: Temperature Regulation Paused Message .......................................................4-28
Figure 4-21: Target Temperature Setting Panel ....................................................................4-29
Figure 4-22: Normothermia Mode ..........................................................................................4-31
Figure 4-23: Out of Normothermia Message..........................................................................4-32
Figure 4-24: Adjustable Alarm Limits .....................................................................................4-41
Figure 4-25: Low Core Temperature Message ......................................................................4-42
Figure 4-26: Temperature Regulation Paused Message .......................................................4-43
Figure 4-27: Thermoregulation is Continuing Message .........................................................4-43
Figure 4-28: Core Readout too Low Message .......................................................................4-44
Figure 4-29: Thermoregulation is Continuing Message ........................................................4-45
Figure 6-1: Selecting Thermal Disinfection Service ...............................................................6-6

Belmont Medical Technologies CritiCool®Operator’s Manual viii
Figure 6-2: Thermal Disinfection Mode ................................................................................. 6-7
Figure 6-3: Thermal Disinfection Mode in Progress .............................................................. 6-7
Figure 6-4: Selecting System Check ..................................................................................... 6-9
Figure 6-5: System Check in Progress.................................................................................. 6-9
Figure 7-1: CureWrap™Connecting Tubes and Special Male Connector ............................. 7-3
Figure 8-1: CliniLogger™Initialization.................................................................................... 8-2
Figure 8-2: CliniLogger™Installation ..................................................................................... 8-2
Figure 8-3: Start Installation .................................................................................................. 8-3
Figure 8-4: Installation Progress ........................................................................................... 8-3
Figure 8-5: Installation Complete .......................................................................................... 8-4
Figure 8-6: CliniLogger™Application Window ....................................................................... 8-5
Figure 8-7: CliniLogger™ Window .......................................................................................... 8-6
Figure 8-8: Choose CliniLogger™File Window...................................................................... 8-7
Figure 8-9: Complete Message ............................................................................................. 8-7
Figure 8-10: CliniLogger™Viewing Panel.............................................................................. 8-8
Figure 8-11: Graphic Display Area ........................................................................................ 8-9
Figure 8-12: Example: Functional Status Area...................................................................... 8-10
Figure 8-13: Example: Modes and Errors Area ..................................................................... 8-10
Figure 8-14: Example of Modes and Error Area.................................................................... 8-13
Figure 8-15: Section of Excel Table ...................................................................................... 8-15
Figure 8-16: Section of Graphic Chart................................................................................... 8-15

Belmont Medical Technologies CritiCool®Operator’s Manual ix
LIST OF TABLES
Table 1-1: Key to Label Symbols ..........................................................................................1-5
Table 2-1: CureWrap™..........................................................................................................2-8
Table 2-2: Disposable Temperature Probes .........................................................................2-11
Table 2-3: Probe and Data Provider Input Specifications......................................................2-11
Table 4-1: CritiCool®Control keys ........................................................................................4-7
Table 4-2: Technical Messages and Alarms .........................................................................4-34
Table 4-3: Clinical Messages ................................................................................................4-37
Table 5-1: Wrap Information .................................................................................................5-1
Table 5-2: Kit Sub Part Number ............................................................................................5-2
Table 5-3: Accessory Part Numbers .....................................................................................5-4
Table 6-1: Inspection and Maintenance Schedule ................................................................6-2
Table 7-1: CritiCool®System Malfunction (No Message) Troubleshooting Guide.................7-2
Table 7-2: Water tank overfilling ...........................................................................................7-3
Table 7-3: CritiCool®System Messages Troubleshooting Guide ..........................................7-4
Table 8-1: Zoom Tool Buttons...............................................................................................8-11
Table 8-2: Mode Codes
.........................................................................................................8-13
Table B-1: Separation Distances in meters ..........................................................................B-1

Chapter 1: Safety Precautions
Belmont Medical Technologies CritiCool®Operator’s Manual 1-1
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®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
physician may result in injury to the patient.
2. The patient should be under constant supervision of the medical staff.
3. The misuse of the temperature regulation equipment can be
potentially harmful to the patient.
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. Following the procedure, a pattern resembling the wrap may appear
for a short period of time on the patient's skin.
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. In order to prevent pressure
sores, hospital routine care should be taken during long thermoregulation
procedures.
6. Do not lift or move the patient by means of the wrap. This may cause tearing
and water leakage from the wrap.
7. Use only core probes or adapters supplied by Belmont Medical Technologies.
8. The technical principles, clinical applications, and risks associated with
circulatory support must be thoroughly understood before using this product.
9. Read the entire manual before attempting to activate the system.

Chapter 1: Safety Precautions
Belmont Medical Technologies CritiCool®Operator’s Manual 1-2
10. Completion of the training program prior to using the CritiCool®system is
mandatory.
11. The repair, calibration, and servicing of the CritiCool®system should be
performed only by Belmont Medical Technologies Ltd. or authorized
agents trained by Belmont Medical Technologies.
12. Prevent any thermal isolation, such as a pillow or other items, between
the CureWrap™and the patient's body.
13. Do not apply heating/cooling to lower extremities during aortic cross
clamping. Thermal injury may occur if heating/cooling is applied to
ischemic limbs.
14. Wraps cannot be placed over transdermal patches due to over excessive
or under medication delivery.
15. 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®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. The desired set-point temperature should be fixed only as prescribed by
and under the order of a clinician.
5. 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 “Trouble-shooting Guide”.).
6. Avoid folds in the wrap—these may obstruct water flow.
7. Do not block the CritiCool®device ventilation grilles. Air must be able toflow
freely in and out in order to keep the device cool.
8. Use sterile 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.
9. When X-ray imaging is performed on a patient wearing a wrap, shadows from
the wrap may appear on the X-ray film.
10. Avoid inserting any sharp object between the patient and the wrap.

Chapter 1: Safety Precautions
Belmont Medical Technologies CritiCool®Operator’s Manual 1-3
EMC Safety
For safe use of the CritiCool®,it is required to keep the CritiCool®at safe distance
from devices emitting radio frequency 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 in order 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.
WARNING!!! The technical principles, clinical applications, and risks
associated with circulatory support must be thoroughly
understood before using this product. Read the entire manual
before attempting to activate the system. Completion of the
training program prior to using the CritiCool®is mandatory.
CAUTION! U.S. Federal law restricts this device to sale by or on the order
of a physician.

Chapter 1: Safety Precautions
Belmont Medical Technologies CritiCool®Operator’s Manual 1-4
Labels
CritiCool®Device Labels
Figure 1-1: Label Placement for the CritiCool®Device.

Chapter 1: Safety Precautions
Belmont Medical Technologies CritiCool®Operator’s Manual 1-5
Label Symbols
Table 1-1: Key to Label Symbols
Description
Symbol
Location of core probe socket
Location of surface probe socket
AC Voltage
Fuse
CE mark of conformity indicates that the product
has received the European approval for MDD
93/42/EEC.
Refer to user manual
Type BF equipment
Recycle for WEEE
Date of manufacture
XX/XX/XXXX
Manufacturer Name
Do not push
Refer to Instruction manual / booklet
Restricts the sale and use of this instrument to
qualified medical personnel only.
Use sterile water only. Tap water usage is not
permitted.

Chapter 2: System Description
Belmont Medical Technologies CritiCool®Operator’s Manual 2-1
CHAPTER 2:
SYSTEM DESCRIPTION
General Description
A growing number of cases require a solution for controlling patient temperature in
various hospital settings. Targeted Temperature Management (TTM) or simply
controlling normothermia is beneficial and sometimes vital.
The CritiCool®system controls TTM in an effective and precise manner. The
desired temperature is preset by the physician with a possible range of target
temperature 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, 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 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.
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® device Use of any
other wrap with the device may harm the patient.

Chapter 2: System Description
Belmont Medical Technologies CritiCool®Operator’s Manual 2-2
CritiCool®System
The CritiCool®system consists of the following elements:
•CritiCool®device
•Wrap
•Accessories
CritiCool®Device
The CritiCool®device has a microprocessor that controls the water
temperature flowing into the wrap worn by the patient.
The decision as to the correct water temperature is based on the desired set
point temperature and the actual measured patient temperature (core and
surface).
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.
The CritiCool®device is equipped with a handle for easy transport.

Chapter 2: System Description
Belmont Medical Technologies CritiCool®Operator’s Manual 2-3
External Features
Front View
Figure 2-1: Front View.

Chapter 2: System Description
Belmont Medical Technologies CritiCool®Operator’s Manual 2-4
Side View
Figure 2-2: Side View.

Chapter 2: System Description
Belmont Medical Technologies CritiCool®Operator’s Manual 2-5
Rear Panel
Wrap
General
Figure 2-3: Rear View.
The wrap is a one-piece wrap with a one-inflow and one or two-return water
connections. It is designed to facilitate the wrapping of individual parts of the body
(chest, arms, thighs, etc.) to maximize surface coverage.