CritiCool User Manual Rev E

Conformity according to the Council Directive 93/42/EEC

Manufactured for: Belmont Medical Technologies 780 Boston Road Billerica, MA 01821 USA Technical Service 885-397-4547 (USA) +1-978-663-0212 (WORLDWIDE) www.BelmontMedTech.com

European Representative: Emergo Europe BV Prinsessegracht 20 2514 AP The Hague The Netherlands Switzerland Authorized Representative: Medenvoy Switzerland Gotthardstrasse 28 6302 ZUG Switzerland

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

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Use of Manual The purpose of this manual is to help medical personnel trained on the usage of this system understand and operate the system. It is important that you read this manual and familiarize yourself thoroughly with its contents before you attempt to operate the system. If you do not understand any part of this manual, or if anything is unclear or ambiguous in any way, please contact your Belmont Medical Technologies representative. The CritiCool® system described in this manual has been designed to meet international safety and performance standards. Only trained medical personnel may operate the system, and these operators must first have a full understanding of the proper operation of the system. The information provided in this manual is not intended to replace regular medical training procedures. This manual should always accompany the system. All qualified personnel operating the system should know the location of the manual. For additional copies of this manual, please contact your Belmont Medical Technologies representative.

Training Belmont Medical Technologies or its authorized distributor will provide training for the system user according to the intended use of the system. It is the responsibility of the hospital management to ensure that only users trained to use the equipment safely operate the system.

Operator Profile Connections and system settings should be performed by a clinical expert in thermoregulation.

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Important Notice No part of this manual may be reproduced or copied in any form by any graphic, electronic or mechanical means - including photocopying, scanning, typing or information retrieval systems - without advanced written permission from Belmont Medical Technologies.

Disclaimer NOTE:

Instructions regarding the reusable temperature probes are NOT applicable for the US market.

Belmont Medical Technologies is not responsible for any consequential or incidental damages or expenses of any kind, impairment of or damage to other goods caused by the following: a. Installed, operated, maintained contrary to Belmont Medical Technologies instructions, notes or warnings under this manual. b. Ignoring any of the warnings, precautions and safety measures indicated in this manual. c. Replacement, repair or alteration not performed by Belmont Medical Technologies or authorized personnel. d. The use of accessories and other parts or equipment made by other manufacturers, whether or not warranted by such manufacturers, which have been attached or connected to the system after installation, unless such accessories and other parts have been supplied and attached or installed by Belmont Medical Technologies. e. Using the system in a contrary manner than indicated in this manual or using the system for any purpose other than indicated in the manual.

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TABLE OF CONTENTS CHAPTER 1: SAFETY PRECAUTIONS ... 11 Definitions ... 11 Intended Use ... 11 Contraindications ... 11 Warnings ... 11 Precautions... 12 EMC Safety ... 13 Improper Use ... 13 Labels ... 14 Label Symbols ... 15 CHAPTER 2: SYSTEM DESCRIPTION ... 17 General Description ... 17 CritiCool® System ... 18 CritiCool® Device ... 18 External Features ... 19 Front View ... 19 Side View... 20 Rear Panel... 21 CureWrap® ... 22 Description and Intended Use ... 22 Wrap Material ... 22 Usage Duration ... 22 Selected Wrap Design ... 24 Accessories ... 24 Temperature Probes ... 24 Detachable Electric Power Cable & Plug ... 27 Connecting Tubes for Wrap ... 27 Male Connector for Draining Water Tank ... 27 Spare Water Filter... 27 Handle ... 27 CliniLogger™ (Optional) ... 27 Temperature Splitter (Optional)... 28 System Specifications ... 28 CritiCool® Technical Specifications ... 29 CliniLogger™ Technical Specifications ... 31 CHAPTER 3: INSTALLATION ... 32 Pre-installation Requirements ... 32 Space and Environmental Requirements ... 32 Electrical Requirements ... 32 Equipment List ... 32 Unpacking and Inspection ... 33 DDT-163-000 Rev. E

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Unpacking CritiCool from the Box ... 33 Assembling the Handle ... 34 Moving the Unit ... 35 Preparation: ... 35 Locking and Unlocking the Trolley Wheels... 35 Packing CritiCool for Shipment ... 35 CHAPTER 4: OPERATING INSTRUCTIONS ... 36 General... 36 CritiCool Functions ... 37 Controls, Functions, Indicators and Connections ... 38 Main Power Switch ... 38 CritiCool® Screen Controls ... 38 QCC- Quick Coupling Connectors ... 39 Temperature Probe Sockets ... 40 Patient Thermoregulation – Step by Step Operation ... 40 Operating the System ... 40 Inserting and Attaching Temperature probes ... 42 Connecting the Water Hoses (Tubes) to CritiCool... 43 Activating the System ... 44 Wrapping the Patient ... 45 The Control Panel ... 45 Patient Mode ... 46 The Main Menu ... 50 Standby Mode ... 51 Mode Select... 52 Temperature Graph ... 54 Settings ... 55 Services ... 58 Modes of Operation ... 60 Normothermia Management ... 67 Replacing the Wrap ... 70 Operation Panel Messages and Alerts ... 71 Safety Messages and Alarms ... 72 Clinical Messages and Alarms ... 73 Technical Messages ... 75 Informative Messages ... 78 TTM Mode Messages ... 79 Controlled Rewarming Mode Messages ... 82 CHAPTER 5: ORDERING INFORMATION ... 84 Equipment and Accessories... 84 Available Wraps ... 84 Available Accessories ... 85 CHAPTER 6: MAINTENANCE ... 87 Introduction ... 87 Service Information ... 87 Routine Maintenance ... 88 DDT-163-000 Rev. E

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

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LIST OF FIGURES Figure 1: Label Placement for the CritiCool® Device. ... 14 Figure 2: Front View... 19 Figure 3: Side View. ... 20 Figure 4: Rear View. ... 21 Figure 5: Measurements. ... 23 Figure 6: Disposable Temperature Probe Connections. ... 26 Figure 7: Handle Assembly. ... 34 Figure 8: Self-Test Screen. ... 40 Figure 9: Mode Select Upon Startup ... 44 Figure 10: Main Screen ... 44 Figure 11: The Control Panel. ... 45 Figure 12: Main Menu. ... 50 Figure 13: Standby Mode ... 51 Figure 14: Select Mode Panel ... 52 Figure 15: Temperature Graph... 54 Figure 16: Settings Screen 1 ... 55 Figure 17: Settings Screen 2 ... 56 Figure 18: Settings Screen 3 ... 56 Figure 19: Settings Screen 4. ... 57 Figure 20: Start Emptying Panel. ... 59 Figure 21: Emptying Water - Performing Panel. ... 59 Figure 22: Core Readout Too Low Message ... 61 Figure 23: Thermoregulation is Continuing Message ... 62 Figure 24: Select Mode Controlled Rewarming. ... 63 Figure 25: Switching to Rewarming Message. ... 64 Figure 26: Controlled Rewarming Mode. ... 64 Figure 27: Temperature Regulation Paused Message ... 65 Figure 28: Target Temperature Setting Panel ... 66 Figure 29: Normothermia Mode ... 68 Figure 30: Out of Normothermia Message ... 69 Figure 31: Adjustable Alarm Limits... 71 Figure 32: Low Core Temperature Message. ... 79 Figure 33: Temperature Regulation Paused Message. ... 80 Figure 34: Thermoregulation is Continuing Message. ... 81 Figure 35: Core Readout too Low Message. ... 82 Figure 36: Thermoregulation is Continuing Message. ... 83 Figure 37: Selecting System Check. ... 92 Figure 38: System Check in Progress. ... 92 Figure 39: CliniLogger™ Initialization. ... 104 Figure 40: CliniLogger™ Installation. ... 104 Figure 41: Start Installation. ... 105 Figure 42: Installation Progress... 105 Figure 43: Installation Complete... 106 Figure 44: CliniLogger™ Application Window. ... 107 Figure 45: CliniLogger™ Window... 108 Figure 46: Choose CliniLogger™ File Window. ... 109 Figure 47: Complete Message. ... 109 DDT-136-000 Rev E Belmont Medical Technologies Page 8 of 121

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

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

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Chapter 1: Safety Precautions

CHAPTER 1: SAFETY PRECAUTIONS Definitions WARNING!!! CAUTION!

Indicates a condition that may endanger the patient or the system operator Indicates a condition that may damage the equipment

NOTE: Indicates ways in which the system’s operation can be made more efficient.

Intended Use CritiCool® is a thermal regulating system, indicated for monitoring and controlling patient temperature.

Contraindications CritiCool® should not be used on patients with open wounds.

Warnings 1.

The physician must be notified if the patient's temperature does not respond properly, does not reach the prescribed temperature, or if there is any change in the prescribed temperature range. Failure to inform the physician may result in injury to the patient.

2.

The misuse of the temperature regulation equipment can be potentially harmful to the patient.

3.

Use only sterile water or 0.22 μm filtered water. Sterile water is recommended.

4.

Do not plug wet probes into the sockets of the CritiCool® device.

5.

The user should verify that no fluids are present at the skin/wrap interface during the procedure. Failure to do so can cause lesions on the patient's skin.

6.

Following the procedure, a pattern resembling the wrap may appear for a short period of time on the patient's skin.

7.

Pressure sores may appear or develop when soft tissue is compressed between a bony prominence and external surface. The use of the CritiCool® system does not prevent this from happening.

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Chapter 1: Safety Precautions 8.

Routine care should be taken during long thermoregulation procedures to prevent pressure sores.

9.

Do not lift or move the patient by means of the wrap. This may cause tearing and water leakage.

10. Prevent any thermal isolation, such as a pillow or other items, between the Wrap and the patient's body. 11. Do not apply heating/cooling to lower extremities during aortic cross clamping. Thermal injury may occur if heating/cooling is applied to ischemic limbs. 12. Wraps cannot be placed over transdermal patches. 13. Wraps should not come in contact with open wounds. 14. CureWrap® should not be in direct contact with open, widespread skin lesions such as burns or dermatitis. 15. Caution should be taken when using CureWrap® with patients that have underlying skin conditions. 16. Do not touch the ribbon cable behind the display and the patient simultaneously. 17. Patients thermoregulated with CritiCool® should be closely monitored at all times.

Precautions 1.

Follow the warning notes listed in the various sections of this manual.

2.

Only trained personnel, familiar with all system operating procedures and certified only by Belmont Medical Technologies or authorized agents of Belmont Medical Technologies are allowed to use the CritiCool® system.

3.

If moisture or leaks are discovered in the connecting hose and/or Wrap, turn off the CritiCool® device, disconnect the power cable from its power source, and correct the problem before proceeding.

4.

If the system sounds an alarm and/or presents a display other than the standard Belmont Medical Technologies display, the operator should proceed according to the display message and/or the troubleshooting instructions ( see “Troubleshooting Guide”).

5.

Avoid folds in the Wrap-these may obstruct water flow.

6.

Do not block the CritiCool® system ventilation grilles. Air must be able to flow freely in and out in order to keep the system cool.

7.

Do not use de-ionized water or water created through reverse osmosis because it may promote corrosion of the metal components of the system.

8.

When X-ray imaging is performed on a patient wearing a wrap, shadows from the wrap may appear on the X-ray film. Connecting water hoses should not be connected to the patient during imaging as they contain metal.

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Chapter 1: Safety Precautions 9.

Avoid inserting any sharp object between the patient and the Wrap.

10. Read all manufacturers’ instructions associated with the temperature probes or temperature probe adapters supplied by Belmont Medical Technologies. 11. Accessories from one system should not be moved or switched out with those from another system to avoid cross-contamination.

EMC Safety For safe use of the CritiCool®, it is required to keep the CritiCool® at a safe distance from systems emitting radio frequency (RF) energy. Refer to Appendix B for recommended separation distances between the CritiCool® and RF source. CAUTION! Power interruptions shorter than 10 minutes return the machine to the mode that was operating before the interruption with a 3-beep alarm. IMPORTANT!

Make sure to read the messages to ensure correct reactivation of the machine.

Improper Use Improper use of the CritiCool® system can lead to skin lesions, electrical hazards, and severe changes in body temperature. CAUTION!

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U.S. Federal law restricts this system to sale by or on the order of a physician.

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Chapter 1: Safety Precautions

Labels CritiCool® System Labels

Figure 1: Label Placement for the CritiCool® Device.

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Chapter 1: Safety Precautions

Label Symbols Table 1: Key to Label Symbols

Description

Symbol

CE mark of conformity indicates that the product has received the European approval for MDD 93/42/EEC. AC Voltage

Fuse

The serial number for this product

Catalogue part number

European Authorized Representative

Switzerland Authorized Representative

Caution – refer to user manual

Type BF equipment

Recycle for WEEE

Date of manufacture XX/XX/XXXX

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Chapter 1: Safety Precautions Name of manufacturer

Country of manufacturer

Do not push

Refer to instruction manual / booklet

Restricts the sale and use of this instrument to qualified medical personnel only. Unique Device Identifier

Instructions for Use

Does not contain natural rubber latex

Medical Device

Do Not Reuse

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Chapter 2: System Description

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

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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 the CritiCool® system. Use of any other wrap with the system may harm the patient.

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Chapter 2: System Description

CritiCool® System The CritiCool® system consists of the following elements:

• • •

CritiCool® device CureWrap® Accessories

CritiCool® Device The CritiCool® device has a microprocessor that controls the water temperature flowing into the wrap worn by the patient. The water temperature is controlled and maintained to the desired set point by measuring the actual patient temperature (core and surface) and adjusting the temperature of the wrap accordingly. Timed pauses of flow during clinical operation regulate the water pressure and water flow in CureWrap. During the initial phase of regulation, the flow cycle is 12 minutes ON (water flows through the wrap) and 1 minute OFF (water recirculates within CritiCool®; no flow through the wrap) in both TTM and Normothermia modes. In a steady state (when the core temperature is within the set point range), the cycle is 12 minutes ON and 12 minutes OFF. If the difference between the patient’s core temperature and the set point temperature exceeds 0.3°C at any time during a timed pause, water will return to the wrap to adjust the patient’s temperature. The CritiCool® device is equipped with a handle for easy transport.

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Chapter 2: System Description

External Features Front View

Figure 2: Front View.

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Chapter 2: System Description

Side View

Figure 3: Side View.

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