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Belmont CritiCool MINI User Manual

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CritiCool
MINI
User Manual
English
DDT-320-000 Rev G.

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  • Page 1 ® CritiCool MINI User Manual English DDT-320-000 Rev G.
  • Page 2 2514 AP The Hague The Netherlands +31 (0) 70 345 8570 Publication No. DDT-320-000 Copyright by Belmont Medical Technologies All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders. DDT-320-000 Rev G Belmont Medical Technologies Page 2 of 114...

  • Page 3: Use Of Manual

    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.

  • Page 4: Important Notice

    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.

  • Page 5: Table Of Contents

    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 Belmont Medical Technologies Page 5 of 114...
  • Page 6 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...

  • Page 7: List Of Figures

    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 .............

  • Page 8: List Of Tables

    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 ...........

  • Page 9: Chapter 1: Safety Precautions

    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 Belmont Medical Technologies Page 9 of 114...

  • Page 10: 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.

  • Page 11: Emc Safety

    ® 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. DDT-320-000 Rev G Belmont Medical Technologies Page 11 of 114...

  • Page 12: Labels

    Labels ® CritiCool MINI Device Labels Figure 1: Label Placement for the CritiCool® MINI Device DDT-320-000 Rev G Belmont Medical Technologies Page 12 of 114...

  • Page 13: Table 1: Labels And Symbols

    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 DDT-320-000 Rev G Belmont Medical Technologies Page 13 of 114...
  • Page 14 Manufacturer name Refer to Instruction manual / booklet Restricts the sale and use of this instrument to qualified medical personnel only. DDT-320-000 Rev G Belmont Medical Technologies Page 14 of 114...

  • Page 15: Chapter 2: System Description

    NOTE: 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. DDT-320-000 Rev G Belmont Medical Technologies...

  • Page 16: Criticool® Mini System

    3-wire cable which grounds the instrument to the power line ground (protective earth) when plugged into an appropriate 3-prong receptacle. WARNING!!! Do not use a 3-to-2-wire adapter with this instrument. DDT-320-000 Rev G Belmont Medical Technologies Page 16 of 114...

  • Page 17: 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. DDT-320-000 Rev G Belmont Medical Technologies...

  • Page 18: External Features

    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.

  • Page 19: Figure 3: Rear View

    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 DDT-320-000 Rev G Belmont Medical Technologies Page 19 of 114...

  • Page 20: Garment/Wrap

    Wrap Material • Patient Side: Non-woven Polypropylene • Exterior: Brushed Loop Fabric Usage Duration The wrap is durable for up to 5 days. Replace the wrap if it • becomes soiled. DDT-320-000 Rev G Belmont Medical Technologies Page 20 of 114...

  • Page 21: Table 2: Curewraps

    Surface temperature probes are used to measure the patient's surface temperature, in a location not covered by the wrap. NOTE: Reusable temperature probes are not available for sale in the USA and select markets. DDT-320-000 Rev G Belmont Medical Technologies Page 21 of 114...

  • Page 22: Reusable Temperature Probes

    CritiCool MINI device. NOTE: The response time for temperature feedback to the CritiCool MINI for all temperature probes once plugged in and attached to the patient is less than 60 seconds.

  • Page 23: Disposable Temperature Probes

    MINI Device. The temperature probe is inserted into the patient and measures core body temperature. Adaptor Cable Disposable Temperature Probe Surface PN# 014-00321 PN# 014-00129 Core PN# 014-00028 PN# 014-00322 Figure 4: Disposable Temperature Probes Connection DDT-320-000 Rev G Belmont Medical Technologies Page 23 of 114...

  • Page 24: System Specifications

    Quick Coupling Connector of the Connecting Tubes. Spare Water Filter The spare water filter is used for annual filter replacement. System Specifications See the following page for system specifications. DDT-320-000 Rev G Belmont Medical Technologies Page 24 of 114...
  • Page 25 MINI , one of Belmont Medical Technologies’ , one of Belmont Medical Technologies’ , one of Belmont Medical Technologies’ temperature regulating systems, induce temperature regulating systems, induce temperature regulating systems, induces s s s , , , , temperature regulating systems, induce maintains and reverses hypothermia in an effective and precise manner.
  • Page 26 Conditions 10-90% Wrap Transport Wrap Transport Wrap Transport Wrap Transport Temperature Temperature Conditions Conditions -20°C to 60°C Temperature Temperature Conditions Conditions Humidity Humidity Conditions Conditions 20-95% Humidity Humidity Conditions Conditions DDT-320-000 Rev G Belmont Medical Technologies Page 26 of 114...
  • Page 27 Data Collected Temperature: Set Point, Core, Surface Data Collected Data Collected Time Water Circulation ON/OFF Water Heat/Cool Mode of Operation Errors CliniViewer Software CliniViewer Software CliniViewer Software CliniViewer Software PC Application DDT-320-000 Rev G Belmont Medical Technologies Page 27 of 114...

  • Page 28: Chapter 3: Installation

    • Quick reference guide ® • Accessory Kit for CritiCool MINI – one of the following: o 200-00200 Accessory Kit with Reusable Temperature Probes o 200-00201 Accessory Kit for Disposable Temperature Probes DDT-320-000 Rev G Belmont Medical Technologies Page 28 of 114...
  • Page 29 Unpacking and Inspection 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. NOTE: Report any container damage prior to opening the container, or...

  • Page 30: Chapter 4: Operating Instructions

    • TTM: Targeted Temperature Management • Controlled Rewarming: Slow rewarming • Normothermia: Fast warming • Empty: This mode appears only at startup. Otherwise, it is found in the Services menu. DDT-320-000 Rev G Belmont Medical Technologies Page 30 of 114...

  • Page 31: Controls, Functions, Indicators And Connections

    NOTE: The alarm icon is an informative icon only. To silence an alarm, the user must press the hard key of the alarm, located to the right of the panel. DDT-320-000 Rev G Belmont Medical Technologies Page 31 of 114...
  • Page 32 The Quick Coupling Connectors are located at the front of the CritiCool MINI device (see circle below) and are connected to the Wrap by the connecting tubes. Quick Coupling Connectors DDT-320-000 Rev G Belmont Medical Technologies Page 32 of 114...
  • Page 33 CritiCool MINI device: • Core – for the core temperature probe • Surface – for the surface temperature probe • Core out – for the core out (temperature out) cable DDT-320-000 Rev G Belmont Medical Technologies Page 33 of 114...

  • Page 34: Patient Thermoregulation - Step By Step Operation

    4. Connect CritiCool MINI to the power source. NOTE: Use only sterile water or 0.22 micron filtered tap water. NOTE: In case of overfilling, see Table 6: Technical Messages and Alarms. DDT-320-000 Rev G Belmont Medical Technologies Page 34 of 114...
  • Page 35 The return of power after shutdown will activate the system to default settings, irrespective of the mode prior to shut down. NOTE: When using CritiCool MINI in TTM mode, it is highly ® recommended to let the CritiCool MINI run before connecting temperature probes and hoses to allow the water to cool.
  • Page 36 Make sure to connect the appropriate probe to its adapter (note the labeling on the adapter). • Be sure to read and follow the instructions for use noted on the temperature probe being used, paying particular attention to indications and contraindications. DDT-320-000 Rev G Belmont Medical Technologies Page 36 of 114...
  • Page 37 Connecting the Water Hoses (Tubes) to CritiCool MINI The Quick Coupling Connectors (QCC) are located at the front of the CritiCool® device. To connect the water tubes to CritiCool® MINI: 1. Before connecting the water tubes, press the metal flange on each QCC to ensure 'open position' of the connector.

  • Page 38: Figure 6: Select Mode Upon Startup

    MINI is turned on, all operating functions are controlled by the LCD Touch Screen. Alternatively, the control panel's hard keys and visual displays guide you through each operational phase as well. DDT-320-000 Rev G Belmont Medical Technologies Page 38 of 114...

  • Page 39: Figure 8: Control Panel

    • CritiCool • OK indicator to indicate that the system is functioning correctly ❹ • Action icons and touch keys ❺ Menu / Escape – Alarm ON / OFF – DDT-320-000 Rev G Belmont Medical Technologies Page 39 of 114...
  • Page 40 This icon is informative only and not an action button. (It is not a touch button). ® Graphical Display of CritiCool MINI Parameters – Set Point / Target Temperature Control – DDT-320-000 Rev G Belmont Medical Technologies Page 40 of 114...

  • Page 41: Figure 9: Main Menu

    Touch the Menu icon A list of options opens: Figure 9: Main Menu The options include the following: • Standby • Mode Select • Temp Graph • Settings • Services DDT-320-000 Rev G Belmont Medical Technologies Page 41 of 114...

  • Page 42: Figure 10: Standby

    (e.g. for intra-transport or CT/MRI imaging). To go to Standby: 1. Touch the MENU icon 2. Touch Standby. Figure 10: Standby DDT-320-000 Rev G Belmont Medical Technologies Page 42 of 114...

  • Page 43: Figure 11: Select Mode Panel

    2. Touch Mode Select to display the select mode panel. Figure 4-7: Select Mode panel Figure 11: Select Mode Panel 3. Touch the required mode icon. The selected mode is now highlighted. 4. Touch OK to activate the mode. DDT-320-000 Rev G Belmont Medical Technologies Page 43 of 114...

  • Page 44: Figure 12: Ttm Mode

    The set point temperature should therefore be set at the beginning of the TTM mode and not changed until the patient should be rewarmed or the desired patient temperature changes. After setting the set point temperature, follow the on-screen instructions DDT-320-000 Rev G Belmont Medical Technologies Page 44 of 114...

  • Page 45: Figure 13: Selecting A Rewarming Step

    Available rates are offered from 0.05°C to 0.5°C per hour in increments of 0.05°C. Figure 13: Selecting a Rewarming Step The selected rewarming step is displayed on the main operating screen as T/h. DDT-320-000 Rev G Belmont Medical Technologies Page 45 of 114...

  • Page 46: Figure 14: Rewarming Step On The Main Screen

    Once the Core Temperature reaches the Target Temperature, the ® CritiCool MINI continues to stabilize the body temperature according to the target temperature. To Start Controlled Rewarming: 1. Touch MENU icon 2. Touch Mode Select. DDT-320-000 Rev G Belmont Medical Technologies Page 46 of 114...

  • Page 47: Figure 15: Select Mode - Controlled Warming

    In the "Controlled Rewarming" mode, the set point display changes to "Target Temperature" with a default of 36.5°C. The "Target" temperature is the temperature at which the Controlled Rewarming process ends. DDT-320-000 Rev G Belmont Medical Technologies Page 47 of 114...

  • Page 48: Figure 17: Low Core Temperature

    2°C below the target temperature, the following message appears: Figure 18: Temperature Regulation Paused Message “Check that the Core Temperature Probe is positioned correctly in the patient and then touch OK to continue rewarming.” DDT-320-000 Rev G Belmont Medical Technologies Page 48 of 114...
  • Page 49 NOTE: The rewarming step and the duration of each step depend on clinical protocols. NOTE: It is recommended to choose steps of 0.2°C - 0.3°C during the rewarming phase. DDT-320-000 Rev G Belmont Medical Technologies Page 49 of 114...

  • Page 50: Figure 19: Out Of Normothermia Message

    (32ºC - 38ºC / 96.8ºF - 100.4ºF), the message OUT OF NORMOTHERMIA appears. Figure 19: Out of Normothermia Message It is possible to set the patient set point temperature between 30°C- 40°C. DDT-320-000 Rev G Belmont Medical Technologies Page 50 of 114...

  • Page 51: Figure 20: Settings Screen 1

    Activate or deactivate the touch screen ❶. • Language ❷ • Default set point temperature ❸ • Temperature scales (Celsius/ Fahrenheit) ❹ • Rewarming step for the controlled rewarming mode. ❺ • DDT-320-000 Rev G Belmont Medical Technologies Page 51 of 114...

  • Page 52: Figure 21: Settings Screen 2

    Low patient temperature ❷ • High water temperature ❸ • Figure 21: Settings Screen 2 Settings Screen 3 Settings Screen 3 includes the Time and Date: Figure 22: Settings Screen 3 DDT-320-000 Rev G Belmont Medical Technologies Page 52 of 114...

  • Page 53: Figure 23: Settings Screen 4

    Settings Screen 4 Settings Screen 4 includes a feature for customizing the System ID of the CritiCool MINI. (ex. MINI 12345) Figure 23: Settings Screen 4 Figure 24: Main Panel with System ID DDT-320-000 Rev G Belmont Medical Technologies Page 53 of 114...

  • Page 54: Figure 25: Set-Point Setting Screen

    2. Use to select the Set Point/Target Temperature to provide a change of 0.1°C. Each tick mark in the scale provides a change of 1.0°C. 3. When finished, touch OK. DDT-320-000 Rev G Belmont Medical Technologies Page 54 of 114...

  • Page 55: Figure 26: Graphic Parameters Display

    The screen can show 1 hour, 6 hours, 12 hours or 24 hours of a temperature ❺. management. Use the double arrows to select the time range The surface temperature graph can be displayed or hidden. DDT-320-000 Rev G Belmont Medical Technologies Page 55 of 114...

  • Page 56: Services

    The Services option is in the Menu panel. Services include the following: Empty • System Check • Technician • Thermal Disinfection • The System Check, technician and thermal disinfection are discussed in “Maintenance”. Figure 27: Select Service DDT-320-000 Rev G Belmont Medical Technologies Page 56 of 114...

  • Page 57: Empty

    5. Touch Services. Touch Empty. The following screen appears. 6. When you are ready for the process to begin, touch Start. The following screen appears. Figure 28: Start Emptying Panel DDT-320-000 Rev G Belmont Medical Technologies Page 57 of 114...

  • Page 58: Replacing The Wrap

    6. Reconnect the connection tubes to the new wrap. 7. When wrapping the patient, follow the instructions for use in the leaflet included with each wrap. DDT-320-000 Rev G Belmont Medical Technologies Page 58 of 114...

  • Page 59: Operation Panel Messages And Alerts

    NOTE: Only authorized users can change the range of the alarms marked by (*) in the settings screen. The user needs to insert a password to enter the settings panel and change the alarm limit. Figure 30: Adjustable Alarm Limits DDT-320-000 Rev G Belmont Medical Technologies Page 59 of 114...

  • Page 60: Safety Messages And Alarms

    The safety messages include: WATER TEMPERATURE TOO LOW • WATER TEMPERATURE TOO HIGH • If such conditions occur, the user should shut down the system and find the cause of the problem. DDT-320-000 Rev G Belmont Medical Technologies Page 60 of 114...

  • Page 61: Clinical Messages And Alarms

    2°C lower than Set Point or when the core temperature is below 31°C. An alarm sounds and thermoregulation and water flow stops. The alarm can be muted for Switching to 5 minutes. Auto Rewarm Mode DDT-320-000 Rev G Belmont Medical Technologies Page 61 of 114...
  • Page 62 It is possible to change the range of these alarms in the Settings screen. The user can choose at which temperatures the "High Patient Temp" and "Low Patient Temp" alarms will be activated. DDT-320-000 Rev G Belmont Medical Technologies Page 62 of 114...

  • Page 63: Technical Messages And Alerts

    Table 6: Technical Messages and Alarms Message Screen Message Connect core temperature probe Check core temperature probe Connect connecting water tubes DDT-320-000 Rev G Belmont Medical Technologies Page 63 of 114...
  • Page 64 Screen Message Message Check water tubes Low battery, connect to power supply Add water DDT-320-000 Rev G Belmont Medical Technologies Page 64 of 114...
  • Page 65 Message Screen Message Tank is empty DDT-320-000 Rev G Belmont Medical Technologies Page 65 of 114...
  • Page 66 Message Screen Message Description Appears when core Body temperature in temperature reaches an accepted range accepted core temperature. Appears after confirming Thermoregulation is low core temperature for continuing… five seconds. DDT-320-000 Rev G Belmont Medical Technologies Page 66 of 114...
  • Page 67 Appears when a set point Out of Normothermia temperature is chosen Range <32°C or >38.0°C (outside of Normothermia Range). Touching OK confirms the new set point temperature and removes the message. DDT-320-000 Rev G Belmont Medical Technologies Page 67 of 114...

  • Page 68: Figure 31: Low Core Temperature Alarm

    This message could indicate that the core temperature probe might be out of place. The following message appears: “Temperature Regulation Paused. Core Readout too Low. Confirm Sensor Position. Press OK to continue.” DDT-320-000 Rev G Belmont Medical Technologies Page 68 of 114...

  • Page 69: Figure 32: Temperature Regulation Paused - Core Readout Too Low Message

    OK to re- activate temperature control. When OK is touched, the screen returns to the main screen and the following message appears for 5 seconds. DDT-320-000 Rev G Belmont Medical Technologies Page 69 of 114...

  • Page 70: Figure 33: Thermoregulation Is Continuing Message

    This message indicates that water is now flowing into the wrap and that thermoregulation is continuing. Once OK has been touched, the Temperature Regulation Paused message will reappear every 30 minutes that its alarm conditions are met. DDT-320-000 Rev G Belmont Medical Technologies Page 70 of 114...

  • Page 71: Controlled Rewarming Mode Messages

    This means that the core temperature probe is probably out of the body. The following message appears, and an audible alarm sounds: Figure 35: Core Readout too Low Message Pressing MUTE disables the audible tone. The alarm restarts after 5 minutes. DDT-320-000 Rev G Belmont Medical Technologies Page 71 of 114...

  • Page 72: Figure 36: 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 36: Thermoregulation is Continuing Message DDT-320-000 Rev G Belmont Medical Technologies Page 72 of 114...

  • Page 73: Chapter 5: Ordering Information

    CHAPTER 5: ORDERING INFORMATION Equipment and Accessories All equipment and accessories may be ordered directly from Belmont Medical Technologies or your local authorized distributor. When ordering parts, specify the part number as listed in this chapter as well as the serial ®...

  • Page 74: Available Accessories

    Available Accessories One accessory kit is provided with each device. The CritiCool MINI Accessory Kit is available in two configurations: one with reusable temperature probes (PN# 200- 00200) and one with adapter cables for use with disposable temperature probes (PN# 200-00201). Refer to Table 8 and Table 9.

  • Page 75: Table 10: Accessories

    Reusable Core Temperature Probe Infant, Gray 014-00021 Reusable Surface Temperature Probe, Green 014-00028 Adapter Cable for Disposable Core Temperature Probes, Gray, Molex 014-00129 Adapter Cable for Disposable Surface Temperature Probes, Green, RJ DDT-320-000 Rev G Belmont Medical Technologies Page 75 of 114...

  • Page 76: Chapter 6: Maintenance

    MINI device. When communicating regarding wraps, refer to the label on the wrap package for lot number details. Replacement of the battery should only be made by a certified Belmont Medical Technologies service engineer. DDT-320-000 Rev G Belmont Medical Technologies...

  • Page 77: Routine Maintenance

    Cleaning and disinfection of the external surface and the water reservoir of the system should be done before each use of the device. The system components may be contaminated during use and storage of the device from numerous factors. DDT-320-000 Rev G Belmont Medical Technologies Page 77 of 114...

  • Page 78: Recommended Disinfectants For External Surfaces

    5. Using a lint free cloth with the disinfectant, disinfect the exterior of the machine, the LCD screen, and the hoses. DDT-320-000 Rev G Belmont Medical Technologies Page 78 of 114...
  • Page 79 Thermal disinfection is performed at every Periodic Maintenance and can only be performed by a Belmont certified technician. Required Equipment Bypass tube PN #200-00181 or PN #200-00096 •...

  • Page 80: Figure 37: Selecting Thermal Disinfection Service

    5. Verify that the tank is full. Connect the bypass tube and touch OK. Thermal Disinfection begins. Countdown appears on the screen. The process takes about 2 to 3 hours. DDT-320-000 Rev G Belmont Medical Technologies Page 80 of 114...

  • Page 81: Cleaning, Disinfecting And Sterilization Of The Reusable Temperature Probes

    The cleaning, disinfection and sterilization of the reusable temperature probes are according to the manufacturer’s instruction. Disposable probes are not to be reused. Improper use can lead to cross contamination and deterioration of safety. DDT-320-000 Rev G Belmont Medical Technologies Page 81 of 114...

  • Page 82: System Check Service

    To perform system check: NOTE: Before performing System Check, verify that the water tank is full. 1. In the main menu, select Services. The following window appears. Figure 40: Selecting System Check DDT-320-000 Rev G Belmont Medical Technologies Page 82 of 114...

  • Page 83: Figure 41: System Check In Progress

    System Check takes about 10 minutes. When the process is complete, a message appears on the screen “SYSTEM CHECK COMPLETED”. 4. Switch to the Operation screen. ® 5. Turn CritiCool MINI OFF. DDT-320-000 Rev G Belmont Medical Technologies Page 83 of 114...

  • Page 84: Filter Replacement

    The filter must be replaced every twelve months at a minimum. NOTE: The filter should be replaced only by Belmont Medical Technologies authorized personnel / authorized biomedical personnel. See the Service Manual for replacement instructions.

  • Page 85: Chapter 7: Troubleshooting

    Should a malfunction occur, consult the Troubleshooting Guide. Troubleshooting Guide Figure 42: CritiCool MINI System Malfunction (No Message) Troubleshooting Guide lists some possible scenarios that may indicate a malfunction, their cause, and recommended actions. Figure 43: Water Tank Overfilling lists water tank overfilling troubleshooting.
  • Page 86 The repair and servicing of the CritiCool MINI system should be performed only by Belmont Medical Technologies or authorized agents of Belmont Medical Technologies. Figure 42: CritiCool MINI System Malfunction (No Message) Troubleshooting Guide Observation Possible Problem Action to be Taken ®...
  • Page 87 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 off CritiCool MINI. DDT-320-000 Rev G Belmont Medical Technologies Page 87 of 114...
  • Page 88 Figure 44: CritiCool MINI System Message Troubleshooting Guide Action to Message Cause of Problem Comments be taken Indicates that an alarm is activated Tank is empty No water in the tank. Open water tank Water tank float is cap. jammed Refill water tank to the maximum.

  • Page 89: Figure 45: Criticool Mini System Message Troubleshooting Guide

    Figure 45: CritiCool MINI System Message Troubleshooting Guide Action to Message Cause of Problem Comments be 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 90: Figure 46: Criticool Mini System Message Troubleshooting Guide

    Figure 46: CritiCool MINI System Message Troubleshooting Guide Action to Message Cause of Problem Comments be taken Core Readout Too Low Core temperature is at Confirm the An alarm issues and least 2°C lower than Set location of the thermoregulation stops. The Point –...

  • Page 91: Figure 47: Criticool Mini System Message Troubleshooting Guide

    Figure 47: CritiCool MINI System Message Troubleshooting Guide Action to Message Cause of Problem Comments be taken Water Temperature Too High When the water Thermoregulation The alarm can be muted for temperature in the stops until the unlimited time. system is more than water cools or the 42°C (107.6°F).

  • Page 92: Figure 48: Criticool Mini System Message Troubleshooting Guide

    Figure 48: CritiCool MINI System Message Troubleshooting Guide Action to Message Cause of Problem Comments be taken Patient’s temperature is below Core temperature is Check that the Thermoregulation XX.X°C below the alarm limit core temperature continues. preconfigured in the probe is in place settings panel.

  • Page 93: Chapter 8: Clinilogger™ Installation And Operating Instructions

    Connect the CliniLogger device to the CritiCool before the start of the medical procedure. ® Belmont Medical Technologies recommends recording CritiCool device data for one patient at a time. At the end of the procedure, disconnect the ™ CliniLogger device from the Thermoregulation machine and connect to a PC.
  • Page 94 When initialization finishes the following screen appears: ™ CliniLogger Installation 5. You can change the installation location by clicking Browse and selecting a new location. Click Next. The License Agreement window appears. DDT-320-000 Rev G Belmont Medical Technologies Page 94 of 114...
  • Page 95 Next. The Start Installation window appears. Start Installation. 7. Click Next; you can follow the installation progress in the progress bars until it finishes. Installation in Progress DDT-320-000 Rev G Belmont Medical Technologies Page 95 of 114...
  • Page 96 8. Click Finish to complete and exit the software installation. 9. Copy "User Ver XX" folder from CD to your desktop. 10. You can now open "User Ver XX." folder and click the CliniLogger.exe file to start the application. DDT-320-000 Rev G Belmont Medical Technologies Page 96 of 114...

  • Page 97: Using The Clinilogger Viewer Application

    CliniLogger is connected – wait for the message. 5. Click Load Logger data, wait for the message. 6. Click Store data and choose a file and a location. DDT-320-000 Rev G Belmont Medical Technologies Page 97 of 114...

  • Page 98: Viewing Downloaded Data

    ™ CliniLogger Viewing Downloaded Data To view downloaded data: ™ ™ 1. Double-click the CliniLogger Viewer icon. The CliniLogger window appears. ™ CliniLogger Window DDT-320-000 Rev G Belmont Medical Technologies Page 98 of 114...
  • Page 99 2. Click Load stored data and choose the file you would like to view. DDT-320-000 Rev G Belmont Medical Technologies Page 99 of 114...
  • Page 100 When the data has been loaded, the “Complete” message appears 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. DDT-320-000 Rev G Belmont Medical Technologies Page 100 of 114...

  • Page 101: Clinilogger Viewing Panel

    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. DDT-320-000 Rev G Belmont Medical Technologies Page 101 of 114...

  • Page 102: Graphic Display Area

    Temperature 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 • DDT-320-000 Rev G Belmont Medical Technologies Page 102 of 114...

  • Page 103: Function Selection Area

    Temperature Settings Wrap Settings Errors/TempStep Settings Example: Modes and Errors Area. Temperature graph control buttons enable modifying the display of each of the temperature graphs. DDT-320-000 Rev G Belmont Medical Technologies Page 103 of 114...
  • Page 104 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. DDT-320-000 Rev G Belmont Medical Technologies Page 104 of 114...
  • Page 105 The values of the temperatures at the cursor line location appear in the window adjacent to the curve color window You can change the time of the Cursor Line on the graph (see Cursor Line in Graphic Display Area). DDT-320-000 Rev G Belmont Medical Technologies Page 105 of 114...
  • Page 106 Rewarming steps between 0ºC and 0.5ºC shown in the example in pink (the step was first 0.4ºC and then changed to 0.2ºC). Error: Period with no control, in the example due to system pause (yellow markings). DDT-320-000 Rev G Belmont Medical Technologies Page 106 of 114...
  • Page 107 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. DDT-320-000 Rev G Belmont Medical Technologies Page 107 of 114...
  • Page 108 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. DDT-320-000 Rev G Belmont Medical Technologies Page 108 of 114...
  • Page 109 User Software. See ‘Installing the Software’ section for more information on this process. Installation Procedure: • Copy the folder “900-00350 CliniLogger Viewer Software_Tech v1.6.3” from the CD to a location on the desired PC • Run the CliniLogger tech.exe application DDT-320-000 Rev G Belmont Medical Technologies Page 109 of 114...

  • Page 110: Appendix A: Belmont Medical Technologies Customer Service

    APPENDIX A: BELMONT MEDICAL TECHNOLOGIES CUSTOMER SERVICE WARNING!!! The following details are necessary to contact your Belmont Medical Technologies representative. Keep this form with the User Manual for scheduling annual periodic maintenance and/or servicing needs. Representative Name: Company Name: Address:...

  • Page 111: Appendix B: Rf Separation

    At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. DDT-320-000 Rev G Belmont Medical Technologies Page 111 of 114...

  • Page 112: Appendix C: Declarations Of Compliance

    APPENDIX C: DECLARATIONS OF COMPLIANCE Guidance and Manufacturer’s declarations of compliance: Table 13: Electromagnetic Emissions – for all ME Equipment and ME Systems DDT-320-000 Rev G Belmont Medical Technologies Page 112 of 114...
  • Page 113 It may be necessary to take mitigation measures, such as re-orienting or relocating the [ME EQUIPMENT or ME SYSTEM] or shielding the location. DDT-320-000 Rev G Belmont Medical Technologies Page 113 of 114...

  • Page 114: Appendix D: Waste Electrical & Electronic Equipment (Weee)

    To prevent possible harm to the environment or human health from uncontrolled waste disposal, please do not dispose of these products as unsorted municipal waste, but instead, hand in at an official collection point for recycling. DDT-320-000 Rev G Belmont Medical Technologies Page 114 of 114...

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