CritiCool MINI User Manual Rev G

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 +1 978.663.0212 Fax 978.663.0214 www.belmontmedtech.com European Representative Emergo Europe BV Prinsessegracht 20 2514 AP The Hague The Netherlands +31 (0) 70 345 8570

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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 DDT-320-000 Rev G

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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 DDT-320-000 Rev G

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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

Date of manufacture YYYY-MM-DD

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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 onboard 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:

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The Belmont Medical Technologies wrap is proprietary to Belmont Medical Technologies and this is the only 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!!!

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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 between 4°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 •

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The wrap is durable for up to 5 days. Replace the wrap if it becomes soiled.

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