CritiCool User Manual Rev 005

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.

Product Complaints/Incident Reporting Report any complaint or problem in the quality, reliability, safety, or performance of this product to Belmont Medical Technologies. If the device has caused or added to patient injury, immediately report the incident to the Belmont Medical Technologies Authorized Representative and Competent Authority of the respective member state or country.

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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 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 Use Of Manual ... 3 Chapter 1: Safety Precautions ... 11 Definitions ... 11 Intended Use ... 11 Patient Target Group ... 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 Clinical Benefits ... 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 Risk of Reuse ... 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 ... 28 Spare Water Filter ... 28 Handle ... 28 CliniLogger™ (Optional) ... 28 Temperature Splitter (Optional) ... 29 System Specifications ... 29 CritiCool® Technical Specifications ... 30 CliniLogger™ Technical Specifications ... 33 Chapter 3: Installation ... 34 Pre-installation Requirements ... 34 Space and Environmental Requirements ... 34 Electrical Requirements ... 34 Equipment List ... 34 Unpacking and Inspection ... 35 Unpacking CritiCool from the Box ... 35 Assembling the Handle ... 36

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Moving the Unit ... 37 Preparation: ... 37 Locking and Unlocking the Trolley Wheels ... 37 Packing CritiCool for Shipment ... 37 Chapter 4: Operating Instructions ... 38 General ... 38 CritiCool Functions ... 38 Controls, Functions, Indicators and Connections... 39 Main Power Switch... 39 CritiCool® Screen Controls ... 39 QCC- Quick Coupling Connectors... 40 Temperature Probe Sockets ... 40 Patient Thermoregulation – Step by Step Operation ... 41 Operating the System ... 42 Connecting the Water Hoses (Tubes) to CritiCool ... 44 Inserting and Attaching Temperature probes ... 45 Activating the System... 46 Wrapping the Patient... 47 The Control Panel ... 48 Patient Mode ... 49 The Main Menu ... 53 Standby Mode ... 54 Mode Select ... 55 Temperature Graph... 57 Settings ... 58 Services ... 60 Modes of Operation... 63 Normothermia Management ... 74 Replacing the Wrap ... 76 Operation Panel Messages and Alerts ... 77 TTM Mode Messages ... 78 Controlled Rewarming Mode Messages ... 81 Chapter 5: Ordering Information ... 83 Equipment and Accessories ... 83 Available Wraps ... 83 Available Accessories ... 84 Chapter 6: Maintenance ... 87 Introduction ... 87 Service Information ... 87 Routine Maintenance ... 88 Routine Maintenance Overview ... 89 Before Each Use ... 90 After Each Use ... 90 Thermal Disinfection (Self-Cleaning) ... 91 System Check Service ... 92 Filter Replacement ... 93 Chapter 7: Troubleshooting ... 94 General ... 94 Troubleshooting Guide ... 94 Chapter 8: Clinilogger™ Installation And Operating Instructions ... 107

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Overview and Installation ... 107 Introduction ... 107 Using the CliniLogger™ Application ... 107 The CliniLogger™ Software ... 107 Installing the Software ... 107 Using the CliniLogger™ Viewer Application ... 110 Downloading Data ... 110 Viewing Downloaded Data ... 112 CliniLogger™ Viewing Panel ... 114 Converting to Excel ... 121 Ending a Viewing Session ... 122 Appendix A: Belmont Medical Technologies Customer Service Representative... 123 Appendix B: EMI / EMC Information ... 124 Appendix C: Waste Electrical & Electronic Equipment (WEEE) ... 126

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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 Core Temperature Probe Connection ... 26 Figure 7: Disposable Surface Temperature Probe Connection ... 27 Figure 8: Handle Assembly. ... 36 Figure 9: Self-Test Screen. ... 42 Figure 10: Halt Error ... 43 Figure 11: Mode Select Upon Startup ... 46 Figure 12: Main Screen ... 47 Figure 13: The Control Panel. ... 48 Figure 14: Settings Screen 1 ... 50 Figure 15: Patient Mode Changed. Check Set Point. ... 50 Figure 16: Main Menu. ... 53 Figure 17: Standby Mode ... 54 Figure 18: Select Mode Panel ... 55 Figure 19: Temperature Graph. ... 57 Figure 20: Settings Screen 1 ... 58 Figure 21: Settings Screen 2 ... 59 Figure 22: Settings Screen 3 ... 59 Figure 23: Settings Screen 4 ... 60 Figure 24: Service Menu ... 60 Figure 25: Start Emptying Panel. ... 61 Figure 26: Emptying Water - Performing Panel. ... 62 Figure 27: Check Water Tubes ... 62 Figure 28: Select Mode Controlled Rewarming. ... 67 Figure 29: Switching to Rewarming Message... 67 Figure 30: Target Temperature Setting Panel ... 69 Figure 31: Holding Core Temp for First Step of Rewarming... 70 Figure 32: Target Temperature Has Been Reached. ... 71 Figure 33: Temperature Regulation Paused Message ... 72 Figure 34: Normothermia Mode ... 75 Figure 35: Out of Normothermia Range ... 76 Figure 36: Adjustable Alarm Limits ... 77 Figure 37: Low Core Temperature Message. ... 78 Figure 38: TTM Mode: Core Readout Too Low Message. ... 79 Figure 39: Thermoregulation is Continuing Message. ... 80 Figure 40: Controlled Rewarming Mode: Core Readout Too Low Message. ... 81 Figure 41: Thermoregulation is Continuing Message. ... 82 Figure 42: Selecting System Check. ... 92 Figure 43: System Check in Progress. ... 93 Figure 44: Male Draining Connector Attached to Connecting Water Hoses (for Emptying) ... 99 Figure 45: CliniLogger™ Initialization. ... 108

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Figure 46: CliniLogger™ Installation. ... 108 Figure 47: Start Installation. ... 109 Figure 48: Installation Progress. ... 109 Figure 49: Installation Complete. ... 110 Figure 51: CliniLogger™ Application Window. ... 111 Figure 52: CliniLogger™ Window... 112 Figure 53: Choose CliniLogger™ File Window. ... 112 Figure 54: Complete Message. ... 113 Figure 55: CliniLogger™ Viewing Panel. ... 114 Figure 56: Graphic Display Area. ... 115 Figure 57: Example: Functional Status Area. ... 116 Figure 58: Example: Modes and Errors Area. ... 116 Figure 59: Example of Modes and Error Area. ... 120 Figure 60: Section of Excel Table. ... 121 Figure 61: Section of Graphic Chart. ... 122

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LIST OF TABLES Table 1: Key to Label Symbols ... 15 Table 2: CureWrap® ... 24 Table 3: Part Numbers: Disposable Temperature Probes and Associated Cables ... 27 Table 4: CritiCool® screen keys ... 39 Table 5: Wrap Information... 83 Table 6: CritiCool Infant Reusable Accessory Kit (PN# 200-00320) ... 84 Table 7: CritiCool Adult Reusable Accessory Kit (PN# 200-00300) ... 84 Table 8: CritiCool Infant Disposable Accessory Kit (PN# 200-00330) ... 85 Table 9: CritiCool Adult Disposable Accessory Kit (PN# 200-00310) ... 85 Table 10: Accessories ... 86 Table 11: Inspection and Maintenance Schedule ... 88 Table 12: CritiCool System Malfunction (no message) Troubleshooting Guide ... 95 Table 13: CritiCool Controlled Rewarming Mode Troubleshooting Guide ... 96 Table 14: Draining CritiCool / Water Tank Overfilled ... 99 Table 15: CritiCool System Technical Alarm Messages Troubleshooting Guide ... 100 Table 16: CritiCool System Technical Alarm Messages Troubleshooting Guide ... 101 Table 17: CritiCool System/Clinical Messages Troubleshooting Guide ... 102 Table 18: CritiCool “Core Readout Too Low” Safety Message Troubleshooting Guide ... 103 Table 19: CritiCool System Messages (Notes) (v6.4 Only) Troubleshooting Guide... 104 Table 20: CritiCool Clinical Messages (Notes) Troubleshooting Guide ... 105 Table 21: CritiCool Clinical Messages (Notes) Troubleshooting Guide ... 106 Table 22: Zoom Tool Buttons ... 118 Table 23: CliniLogger Mode Codes ... 120 Table 24: Guidance and Manufacturer’s Declaration – Emissions ... 124 Table 25: Guidance and Manufacturer’s Declaration – Immunity ... 125

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Chapter 1: Safety Precautions

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.

Patient Target Group CritiCool can be used with infant, pediatric and adult patients.

Contraindications CureWrap® should not come into contact with open wounds. Caution should be taken when using CureWrap with patients with underlying skin conditions.

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 being thermoregulated 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.

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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Chapter 1: Safety Precautions 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. Power interruptions of 10 minutes or longer return the machine to the parameters selected in the Settings menu.

IMPORTANT!

Make sure to read the messages to ensure correct reactivation of the machine. If a power outage occurs when using Controlled Rewarming Mode, the user should reinitiate Controlled Rewarming Mode. See page 72 for instructions.

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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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

Name of manufacturer

Country of manufacturer

Do not push

Refer to instruction manual / booklet

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Chapter 1: Safety Precautions Description

Symbol

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

Not safe in MRI

Use sterile or 0.22 µ filtered water only. Tap water usage is not permitted.

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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 on-board body temperature control algorithm at 133 millisecond intervals, delivers the optimum water temperature to reach the desired set point temperature. The cooling/heating pump brings the water to the required temperature and the pump circulates it through the specially designed flexible and single piece CureWrap®. The CureWrap® is designed to be in close contact with a large area of the body, thus allowing optimization of energy transfer. WARNING!

The Belmont Medical Technologies wrap is proprietary to Belmont Medical Technologies and this is the only wrap authorized to be used with the CritiCool® system. Use of any other wrap with the system may harm the patient.

Clinical Benefits The use of active thermoregulation (TTM and normothermia) treatment has shown that the benefits outweigh the risks, with improvements in patient morbidity and mortality.

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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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Chapter 2: System Description

Rear Panel

Figure 4: Rear View.

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