Belmont Medical Technologies CritiCool User Manual
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Belmont Medical Technologies CritiCool User Manual

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

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Summary of Contents for Belmont Medical Technologies CritiCool

  • Page 1 CritiCool ® User Manual The Coolest Solution for TTM DDT-136-000 Rev. D English...
  • Page 2 Emergo Europe BV Prinsessegracht 20 2514 AP The Hague The Netherlands +31 (0) 70 345 8570 Copyright 2019 by Belmont Medical Technologies. All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders. Belmont Medical Technologies CritiCool Operator’s Manual...

  • Page 3: Use Of 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.

  • Page 4: Important Notice

    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.

  • Page 5: Table Of Contents

    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 ®...
  • Page 6 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 ®...
  • Page 7 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...
  • Page 8 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 ....................
  • Page 9 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 viii...
  • Page 10 ......................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 ....................

  • Page 11: Chapter 1: Safety Precautions Definitions

    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 happenin .

  • Page 12: Precautions

    Chapter 1: Safety Precautions Completion of the training program prior to using the CritiCool system is ® mandatory. 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.

  • Page 13: Emc Safety

    Chapter 1: Safety Precautions 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.

  • Page 14: Labels

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

  • Page 15: Label Symbols

    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. Belmont Medical Technologies CritiCool Operator’s Manual ®...

  • Page 16: System Description

    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. Belmont Medical Technologies CritiCool ®...

  • Page 17: Criticool ® System

    Chapter 2: System Description 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.

  • Page 18: External Features

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

  • Page 19: Side View

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

  • Page 20: Rear Panel

    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. Belmont Medical Technologies CritiCool ®...
  • Page 21 Exterior: Brushed Loop Fabric Usage Duration The wrap is durable for up to 5 days. However, it is recommended to replace the wrap in occasions of soiling Fastening method Velcro (unlimited repeated use) Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 22: Figure 2-4: Measurements

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

  • Page 23: Accessories

    Chapter 2: System Description Selected Wrap Design Belmont Medical Technologies offers disposable wraps in a wide range of sizes. Table 2-1: CureWrap ™ Number of wraps Patient Size/ Wrap Height/ Type per Box Weight Width (m) Infant 508-03518 Box (X8; single size) 2.5-4Kg...
  • Page 24 All instructions regarding the reusable temperature probes are NOT applicable for USA market There are three color-coded temperature probes: Core (gray), Surface (green), and Infant Core (gray). Both core and surface probes must be plugged into the CritiCool device. The ®...

  • Page 25: Figure 2-5: Disposable Temperature Probe Connections

    Disposable Surface Temperature Probe: The disposable surface temperature probe is attached to the reusable surface adapter (green). The adapter is plugged into the green surface socket at the front of the CritiCool ® device. The temperature probe is attached to the patient's skin and measures surface body temperature.

  • Page 26: System Specifications

    3. Detachable Electric Power Cable & Plug See Table 5-2, “Kit Sub Part Number”. 4. Connecting Tubes for Wrap Two flexible 2.58 m long, color-coded connecting tubes, connect the wrap with the CritiCool ® device to enable the flow of water between them.
  • Page 27 ® , one of Belmont Medical Technologies Temperature Regulating systems, induces, maintains, and reverses hypothermia in an effective and precise manner. The desired patient temperature is preset by the physician with a possible range of target temperature from mild Hypothermia to Normothermia.

  • Page 28: Chapter 3: Installation

    ® should be operational upon delivery. The unit should be unpacked, installed and tested only by Belmont Medical Technologies authorized personnel. No attempt should be made by the purchaser to unpack or assemble the unit alone.

  • Page 29: Assembling The Handle

    • Power cord • User manual • Quick reference guide • Accessories Kit for CritiCool – one of the following (See Table 5-2): ® – 200-00300 Accessory Kit Adult with reusable temperature probes – 200-00310 Accessory Kit Adult disposable –...

  • Page 30: Moving The Unit

    Chapter 3: Installation Moving the Unit Preparation: Before moving the unit: Ensure that the CritiCool device is off by pressing the ON / OFF switch. ® Ensure that all electrical connections are disconnected. Locking and Unlocking the Trolley Wheels The CritiCool device trolley has four wheels.

  • Page 31: Operating Instructions

    Chapter 4: Operating Instructions HAPTER PERATING NSTRUCTIONS General This chapter contains: • Application specification • Detailed operating instructions for the CritiCool system for the different ® modes of operation. • A description of the controls, indicators and connections for the CritiCool device ®...

  • Page 32: Getting Started

    To prepare the system for operation: Place the unit in the desired position according to “Space and Environmental Requirements”. Press the brake pedals and lock the wheels to secure the CritiCool device. ® Remove the water tank feeder cover and pour in sterile water until the maximum allowable level is reached.

  • Page 33: Figure 4-1: Self-Test Screen

    Controlled Rewarming – Empty the System Targeted Temperature Management (TTM) mode is highlighted below. Figure 4-2: Mode Select Upon Startup. Select the TTM mode and touch OK. The Thermoregulation Main Screen Control Panel appears. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 34: Inserting And Attaching Temperature Probes

    Mode on 4-9. In order to begin, the tubes and wrap must be connected, as well as the appropriate temperature probes. NOTE: It is highly recommended to let the CritiCool ® run for 20 – 30 minutes before connecting temperature probes and tubes, allowing the water in the system to cool down before the treatment begins.

  • Page 35: Wrapping The Patient

    NOTE: Before connecting the water tubes, press the metal flange on each QCC to ensure 'open position' of the connector. To connect the water tubes to the CritiCool ® unit: 1. Lock the connecting tubes by pressing them against the connectors;...
  • Page 36 NOTE: If the clamps to the wrap are closed, water will not flow to the wrap, and you will notice the disappearance of the OK symbol in the top left corner. 3. Connect water tubes to wrap and to the CritiCool ®...

  • Page 37: Criticool ® Screen Control Keys

    The CritiCool ® screen is a touch screen. In addition to the four soft keys, there are five hard keys to the right of the panel that you can use. Table 4-1: CritiCool ® Control keys Icon Description Main Menu and Escape...

  • Page 38: The Control Panel

    ❹ • OK indicator to indicate that water is flowing into the wrap and the Action Icons and Touch keys ❺ • – Menu / Escape – Alarm ON Belmont Medical Technologies CritiCool Operator’s Manual ®...

  • Page 39: Patient Mode

    NOTE: The Alarm icon appears only if there is an Alarm condition. This icon is informative only and not an action button (It is not a touch button). – Graphical Display of CritiCool ® Parameters – Set Point / Target Temperature Control...
  • Page 40 Neonatal or Adult. The new Patient Mode will now be highlighted with a white box. NOTE: The Neonatal and Adult modes have different settings during operation. Press OK to finalize the change. The Main Screen will now show the new Patient Mode icon. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-10...

  • Page 41: Neonatal Mode

    Temperature for Adult Mode, press Settings. You will be asked to enter the passcode, which can be found in the manual under Settings on page 4-18. Enter the code and then press OK. Belmont Medical Technologies CritiCool ® Operator’s Manual...
  • Page 42 Core Temperature is below 31.0°C: the following operating conditions occur: If Core> 31.0°C: Thermoregulation is paused, but the machine continues to flow cold water to the wrap, so the patient does not rewarm. NOTE: This differs from Neonatal Mode. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-12...

  • Page 43: The Main Menu

    When you touch the Menu icon . A list of options opens. Figure 4-5: Main Menu. The options include the following: • Standby • Mode Select • Temp Graph • Settings • Services Belmont Medical Technologies CritiCool ® Operator’s Manual 4-13...

  • Page 44: Standby Mode

    Standby Mode for extended periods of time, the patient may become too warm or cold. It is important for the patient to be monitored by the clinical team during all phases of treatment, including when CritiCool is in Standby Mode.

  • Page 45: Mode Select

    Touch the required mode icon. The selected mode is highlighted. Touch OK to activate the mode. NOTE: The selected mode is shown at the top of the control panel (see “the Control Panel”). Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 46: Ttm (Targeted Temperature Management)

    This mode should not be used for cooling patients. It does not have stepwise rewarming and warms the patient as fast as possible. NOTE: When switching to Normothermia Management, the system keeps the last set point of the preceding mode. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-16...

  • Page 47: Shutting Down The Device

    1. Touch the MENU icon 2. Touch Temp Graph. 3. Once entering the temperature graph, the following is showed: Figure 4-8: Temperature Graph. NOTE: The Surface Temperature Graph can be displayed or hidden. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-17...

  • Page 48: Settings

    The passcode for the Settings screen is __________. To pre-configure the settings: 1. From the Menu panel choose Settings. 2. Enter the password. The Settings window appears. 3. Touch the page numbers to move between the pages. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-18...
  • Page 49 Settings Screen 2 ❶ ❷ ❸ Figure 4-10: Settings Screen 2. • High Patient temperature ❶ Settings Screen 2 includes adjustable alarm limits, for: • Low Patient temperature ❷ • High Water temperature ❸ Belmont Medical Technologies CritiCool ® Operator’s Manual 4-19...
  • Page 50 Setting Screen 4 includes the Time and Date settings. 4. Touch OK to confirm settings changes and to return to the control panel. NOTE: Touching the ESC soft key returns to the main screen without saving any changes. Belmont Medical Technologies CritiCool Operator’s Manual 4-20...

  • Page 51: Services

    ® To empty the water tank: 1. Disconnect the wrap from the system. Dispose of the wrap. 2. Connect an emptying tube to the "water out" of the CritiCool ® device and direct the tube to a bucket or sink for water collection.

  • Page 52: Modes Of Operation

    Modes of Operation Targeted Temperature Management (TTM) Mode When the CritiCool ® device starts you are prompted to confirm the mode, and an audio alarm sounds. TTM is highlighted by default.
  • Page 53 3. When you finish, touch OK. NOTE: The icons change the temperature by 0.1°C. Using the scales changes the temperature by 1°C. After adjusting the set point, the CritiCool ® device automatically operates at the optimal level to obtain the desired set-point temperature.

  • Page 54: Figure 4-15: Core Readout Too Low Message

    OK button is touched. When you touch OK, the screen returns to the Main Screen and a message appears for 5 seconds to indicate that thermoregulation has resumed. Belmont Medical Technologies CritiCool Operator’s Manual 4-24 ®...

  • Page 55: Controlled Rewarming Mode

    Chapter 4: Operating Instructions Figure 4-16: Thermoregulation is Continuing Message. Controlled Rewarming Mode This mode is used for Controlled Rewarming following TTM. In Controlled Rewarming mode the CritiCool ® increases the set-point automatically in small steps. Controlled Rewarming Process The Controlled Rewarming process starts with the mild hypothermia temperature.
  • Page 56 Insert password and press the OK button. Choose the required Rewarming Step. Touch OK to return to the Main Screen. To Start Controlled Rewarming: 1. Touch MENU icon 2. Touch Mode Select to open the MODE SELECT panel. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-26...

  • Page 57: Figure 4-17: Select Mode Controlled Rewarming

    5. Touch OK to confirm correct Core temperature and to start the rewarming process. 6. Use the Set Temperature icon to change the Target temperature. NOTE: The Target temperature is the temperature at which the controlled rewarming process ends. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-27...

  • Page 58: Figure 4-19: Controlled Rewarming Mode

    The system proceeds to increase the virtual set point until the Target temperature is reached. NOTE: In the main screen, the "Next Step" shows the VSP / 0.5 hour. When Core temperature reaches the Target temperature the CritiCool ® continues to maintain the body temperature according to the target temperature.

  • Page 59: Target Temperature Setting

    Target Temperature. Touch OK to confirm. NOTE: The icons provide a change of 0.1ºC. Each scale mark i n the toolbar provides a change of 1ºC. Figure 4-21: Target Temperature Setting Panel. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-29...

  • Page 60: Manual Rewarming

    Repeat the procedure until the patient reaches target temperature. The Set Point step and the duration of each step depend on hospital protocol. When choosing small steps, the CritiCool will keep water temperature ®...

  • Page 61: Figure 4-22: Normothermia Mode

    3. Touch OK to confirm. NOTE: The icons provide a change of 0.1ºC. Each scale mark in the toolbar provides a change of 1ºC. The CritiCool ® device automatically operates at the optimal level to obtain the desired set-point temperature so that, when in Normothermia mode, the difference between the set point temperature and the core temperature does not affect the heating rate.

  • Page 62: Exceeding The Normothermia Range

    (32ºC to 38ºC / 89.6ºF to 100.4ºF), the message OUT OF NORMOTHERMIA appears. Figure 4-23: Out of Normothermia Message. It is possible to to set the set point above 38ºC or below 32ºC. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-32...

  • Page 63: Replacing The Wrap

    10. Wait for the new wrap to fill up with water then secure it to the patient with the Velcro strips. The system is ready. NOTE: If there is not enough water in the tank after filling the wrap, the system alert message ADD WATER appears Belmont Medical Technologies CritiCool ® Operator’s Manual 4-33...

  • Page 64: Operation Panel Messages

    Alarms sounds are different from those of the Clinical Alarms. Technical Messages The following technical messages might appear: Table 4-2: Technical Messages and Alarms Message Screen Message Tank is empty Add Water Belmont Medical Technologies CritiCool ® Operator’s Manual 4-34...
  • Page 65 Chapter 4: Operating Instructions Table 4-2: Technical Messages and Alarms Message Screen Message Connect Water Tubes Connect Core temperature probe Check Water Tubes Belmont Medical Technologies CritiCool ® Operator’s Manual 4-35...
  • Page 66 Table 4-2: Technical Messages and Alarms Message Screen Message Check Core temperature probe Follow the instruction of the technical messages, (for example add water if necessary, or connect sensors if they are not connected etc.). Belmont Medical Technologies CritiCool ® Operator’s Manual 4-36...

  • Page 67: Clinical Messages

    Main Screen and a message appears for 5 seconds indicating that thermoregulation has resumed. Switching to AutoRe- Confirm the patient's temperature warm Mode before switching to Rewarming mode. Once confirmed, touch OK to continue. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-37...
  • Page 68 NOTE: It is possible to change the range of some of these alarms in the Settings screen. The user can choose at which temp the "High Patient Temp" and "Low Patient Temp" alarms will be activated. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 69: Safety Messages And Alarms

    The Safety messages include: • WATER TEMP. TOO LOW • WATER TEMP. TOO HIGH If such condition occurs, you should consider shutting down the system and finding the cause of the problem. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-39...

  • Page 70: Informative Messages

    Out of Normothermia Appears when you choose Range Set Point temperature for Normothermia <32°C and >38.0°C. For this message, thermoregulation continues. Touching OK confirms the New Set Point temperature and removes the message. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-40...

  • Page 71: Constant Alarms

    (*) in the Settings screen. The user needs to insert a password to enter the Settings panel and change the alarm limit. Figure 4-24: Adjustable Alarm Limits. Constant Alarms Constant alarms occur in the following states: • Halt condition • Select Mode screen Belmont Medical Technologies CritiCool ® Operator’s Manual 4-41...

  • Page 72: Ttm Mode Messages

    C. Core temperature is lower than the Set Point by more than 2°C ( (Tsp- Tcore)> 2°C) or if Tc < 31°C In this condition an audible alarm sounds and the following message appears: Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 73: Figure 4-26: Temperature Regulation Paused Message

    After confirming the temperature, the alarm is silenced. It will return after 30 minutes if the Core temperature is still too low. NOTE: If the Core Temperature is below 30.5°C, the alarm cannot be silenced. Belmont Medical Technologies CritiCool ®...

  • Page 74: Controlled Rewarming Mode Messages

    Patient Core Temp< Target Temp but ( Virtual SP-Core Temp)>2°C This means that the Core sensor is probably out of the body. In this condition: The following message appears, and an audible alarm sounds. Figure 4-28: Core Readout too Low Message. Belmont Medical Technologies CritiCool ® Operator’s Manual 4-44...

  • Page 75: Figure 4-29: Thermoregulation Is Continuing Message

    30 minutes- The alarm cannot be silenced. When OK is touched, the screen returns to the Main Screen and the following message appears for 5 seconds. Figure 4-29: Thermoregulation is Continuing Message. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 76: Chapter 5: Ordering Information

    NFORMATION Equipment and Accessories All equipment and accessories may be ordered directly from your local Belmont Medical Technologies representative. When ordering parts, specify the model number as listed in this chapter as well as the serial number of your CritiCool ®...

  • Page 77: Table 5-2: Kit Sub Part Number

    Chapter 5: Ordering Information Table 5-2: Kit Sub Part Number 200-00300 ACC. Kit Adult Reusable (CritiCool) Sub Part No. Description Sub Quantity 007-00169 Cork Ball Chain 007-00170 Chain connector clear 4.5mm 014-00020 Reusable Core Temperature Probe Adult, Gray 014-00021 Reusable Surface Temperature probe, Green...
  • Page 78 Chapter 5: Ordering Information Table 5-2: Kit Sub Part Number 200-00320 Acc. Kit Infant, Reusable (CritiCool) Sub Part No. Description Sub Quantity 007-00169 Cork Ball Chain 007-00170 Chain connector clear 4.5mm 014-00005 Reusable Core Temperature Probe Infant, Gray 014-00021 Reusable Surface Temperature probe, Green...

  • Page 79: Table 5-3: Accessory Part Numbers

    Reusable Surface Temperature Probe, Green 014-00321 Disposable Surface Temperature Probe RJ, 20/pack 014-00028 Adaptor Cable for Disposable Core Temperature Probe, Gray 014-00129 Adapt Cable for Disposable Surface Temperature Probe RJ, Green 007-00365 Handle for CritiCool ® Unit 017-00250 CliniLogger ™ Belmont Medical Technologies CritiCool ®...

  • Page 80: Chapter 6: Maintenance

    Chapter 6: Maintenance HAPTER AINTENANCE Introduction This chapter outlines the maintenance instructions for the CritiCool ® system. Qualified hospital staff may perform routine maintenance unless otherwise specified. WARNING!!! The repair and servicing of the CritiCool ® system should be performed only by Belmont Medical Technologies or authorized agents of Belmont Medical Technologies.

  • Page 81: Cleaning And Disinfection

    Thermal Disinfection application * Filter replacement could be performed if needed more frequently than once a year (according to water quality). Cleaning and Disinfection The cleaning and disinfecting of the CritiCool ® includes both external and internal cleaning and disinfection.

  • Page 82: Required Tools For Cleaning And Disinfection

    2. Make sure that the system is turned off and unplugged from power. 3. Using a lint free cloth with sterile water, clean the exterior of the machine, the LCD screen, the hoses, the power cord and the reusable temperature probes* from any soiling. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 83: Before Storage

    Dispose of the disposable temperature probes in a designated place. 5. Drain the water using the emptying tube. NOTE: The emptying process is an integrated feature of the CritiCool ® Refer to the Emptying instruction in the User Manual on page 4-21.

  • Page 84: Thermal Disinfection

    CAUTION! Do not apply physical pressure on the screen. 11. Store the machine in a cool and dry place. Thermal Disinfection The thermal disinfection of the CritiCool ® is an integrated feature, which heats the circulating water of the system, thus allowing the heat to disinfect the water tank and hoses from contamination.

  • Page 85: Thermal Disinfection Process

    1. In the main menu select Services. Figure 6-1: Selecting Thermal Disinfection Service. 2. Touch Thermal Disinfection and then OK. 3. The process is password protected. Insert password. 4. Touch OK. The following verification message appears: Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 86: Figure 6-2: Thermal Disinfection Mode

    OK. Thermal Disinfection begins. Countdown appears on the screen. The process takes about 2 to 3 hours. Figure 6-3: Thermal Disinfection Mode in Progress CAUTION! Do not touch the machine or hoses during the self-cleaning process. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 87: Cleaning, Disinfecting And Sterilization Of The Reusable Temperature Probes

    The System Check service performs a complete check of the system by checking the functionality of the following components: • Screen and buzzer • Pump • Wrap connection • Pressure meter • Heating and Cooling unit • Temperature of water inflow and water outflow Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 88: Figure 6-4: Selecting System Check

    Successful completion of the system check service indicates that the CritiCool device is operational. ® NOTE: If the CritiCool ® was out of use for a long time, it is recommended to perform full System Check. To perform system check: NOTE: Before performing System Check, verify that the water tank is full.

  • Page 89: Filter Replacement

    The filter must be replaced every twelve months. NOTE: The filter should be replaced only by Belmont Medical Technologies authorized personnel. See the Service Manual / Filter Replacement- Step by Step for replacement instructions.

  • Page 90: Chapter 7: Troubleshooting

    Table 7-1 lists some possible symptoms that indicate malfunctions that do not appear on the message display, their cause, and recommended actions. Table 7-2 lists water tank overfilling troubleshooting Table 7-3 provides a list of fault messages that appear on the CritiCool ® device screen. Belmont Medical Technologies CritiCool ®...
  • Page 91 Chapter 7: Troubleshooting WARNING!!! The repair and servicing of the CritiCool ® system should be per- formed only by Belmont Medical Technologies or authorized agents of Belmont Medical Technologies. Table 7-1: CritiCool System Malfunction (no message) Troubleshooting Guide ® Observation...

  • Page 92: Figure 7-1: Curewrap ™ Connecting Tubes And Special Male Connector

    ® device ON. Select Empty mode in Services. Allow the excess water to drain into a receptacle, pail or sink. When the desired water level has been reached, turn the CritiCool ® device OFF. Special Male Connector for Draining Water Tank Figure 7-1: CureWrap ™...

  • Page 93: Table 7-3: Criticool ® System Messages Troubleshooting Guide

    Chapter 7: Troubleshooting Table 7-3: CritiCool ® System Messages Troubleshooting Guide Action to be Message Cause of Problem Comments taken Indicates that an alarm is activated Tank is empty No water in the tank. Refill water tank Water tank float is to maximum level.
  • Page 94 Chapter 7: Troubleshooting Table 7-3: CritiCool System Messages Troubleshooting Guide ® Action to be Message Cause of Problem Comments taken Connect Core temperature probe No core temperature Connect core * Pressing Alarm Mute probe is inserted in its temperature probe silences the buzzer for 30 socket.
  • Page 95 Chapter 7: Troubleshooting Table 7-3: CritiCool ® System Messages Troubleshooting Guide Action to be Message Cause of Problem Comments taken Core Readout too Low This message appears Once the operator An alarm issues and when Core Temp. is at confirmed the thermoregulation stops.
  • Page 96 Chapter 7: Troubleshooting Table 7-3: CritiCool ® System Messages Troubleshooting Guide Action to be Message Cause of Problem Comments taken Water temp. too High When the water Thermoregulation The alarm can be muted for temperature in the stops until the an unlimited time.
  • Page 97 Chapter 7: Troubleshooting Table 7-3: CritiCool ® System Messages Troubleshooting Guide Action to be Message Cause of Problem Comments taken Patient’s temperature is below The message appears Check Core Thermoregulation XX.X°C with an alarm when temperature probe continues. Core temperature is...

  • Page 98: Overview And Installation

    PERATING NSTRUCTIONS Overview and Installation Introduction The purpose of the CliniLogger ™ device is to save the CritiCool ® Allon ® systems' vital data for further reference. By means of the CliniLogger ™ Viewer software, the user can use an external PC to review this saved data.

  • Page 99: Figure 8-1: Clinilogger ™ Initialization

    When initialization finishes the following screen appears. Figure 8-2: CliniLogger ™ Installation. 5. You can change the installation location by clicking Browse and selecting a new location. Click Next. The License Agreement window appears. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 100: Figure 8-3: Start Installation

    Next. The Start Installation window appears. Figure 8-3: Start Installation. 7. Click Next; you can follow the installation progress in the progress bars until it finishes. Figure 8-4: Installation Progress. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 101: Figure 8-5: Installation Complete

    8. Click Finish to complete and exit the software installation. 9. Copy "User Ver 1.6" folder from CD to your desktop. 10. You can now open "User Ver 1.6.2." folder and click the CliniLogger.exe file to start the application. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 102: Using The Clinilogger ™ Viewer Application

    COM 1 –10 port or you can use with USB to RS232 adaptor. 4. Click Connect to Logger, the software traces the COM port where the CliniLogger ™ is connected – wait for the message. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 103: Viewing Downloaded Data

    To view downloaded data: 1. Double-click the CliniLogger ™ Viewer icon. The CliniLogger ™ window appears. Figure 8-7: CliniLogger ™ Window. 2. Click Load stored data and choose the file you would like to view. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 104: Figure 8-8: Choose Clinilogger ™ File Window

    When the data has been loaded the “Complete” message appears Figure 8-9: Complete Message. 3. Click View data - the graph opens. 4. To convert to Excel, click Convert to Excel – the data is presented in Excel format. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 105: Clinilogger ™ Viewing Panel

    / Allon ® • Software version of the thermoregulation device • Close Window button • Function Selection area: Control keys • Graphic Display area with a graphic presentation of the Thermoregulation system variables. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 106: Graphic Display Area

    Temperatures graphs: Set-point, Core and Surface as a function of time • Modes and Error area: Thermoregulation modes, Rewarming step and errors as a function of time • Device Functional Status area: Heat/Cool and Pump On/Off Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 107: Function Selection Area

    Temperature Settings Wrap Settings Errors/TempStep Settings Figure 8-13: Example: Modes and Errors Area. Temperature graph control buttons enable modifying the display of each of the temperature graphs. Belmont Medical Technologies CritiCool ® Operator’s Manual 8-10...

  • Page 108: Display/Hide Buttons

    X and move the cursor to the Temperature graph; Y directions the cursor image changes to the button icon. Click the mouse to zoom out. You can click again to zoom out again. Belmont Medical Technologies CritiCool ® Operator’s Manual 8-11...

  • Page 109: Cursor Line

    NOTE: To return to the original display click the unzoom button Cursor Line The values of the temperatures at the cursor line location appear in the window adjacent to the curve color window (see in Figure 8-10). Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 110: Modes And Error Area

    Error: Period with no control, in the example due to system pause (yellow markings). Figure 8-14: Example of Modes and Error Area. Table 8-2: Mode Codes Code Indicates PowerUp Cooling Adult PowerUp Cooling Neonate PowerUp Warming Adult PowerUp Warming Neonate Belmont Medical Technologies CritiCool ® Operator’s Manual 8-13...

  • Page 111: Functional Status Area-Heat/Cool And Pump On/Power Off

    Functional Status Area – Heat/Cool and Pump On/ Power Off The graphs indicate the state of the wrap: Heat / Cool modes and the On/Off of water circulation in the wrap. Heat/Cool- When CritiCool ® is cooling the water in the tank- the line is blue.

  • Page 112: Converting To Excel

    A second page in the Excel file shows a graphic description of the Excel table with the Y axis showing the temperatures, and the X axis the Excel table lines. Figure 8-16: Section of Graphic Chart. Belmont Medical Technologies CritiCool ® Operator’s Manual...

  • Page 113: Ending A Viewing Session

    Chapter 8: CliniLogger Installation and Operating Instructions ™ Ending a Viewing Session To end a session: Click Quit on the Main Menu to exit the Viewing Session Belmont Medical Technologies CritiCool ® Operator’s Manual 8-16...

  • Page 114: Belmont Medical Technologies Customer Service Representative

    Belmont Medical Technologies USTOMER ERVICE EPRESENTATIVE WARNING!!! The following details are necessary to contact your Belmont Medical Technologies representative. Keep this form with the User Manual for ease in case your CritiCool ® device is in need of service. Representative Name:...

  • Page 115: Appendix B: Rf Separation

    ® plus CliniLogger ™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the CritiCool ® plus CliniLogger ™ recommended below, according to the maximum output power of the communications equipment.

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