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Belmont Medical Technologies CritiCool User Manual

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CritiCool
User Manual
DDT136000 Rev. 004 English

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  • Page 1 ® CritiCool User Manual DDT136000 Rev. 004 English...
  • Page 2 2) Scan the QR code to the left. To request a printed or previous version of a user manual, please contact: resources@belmontmedtech.com Copyright by Belmont Medical Technologies. All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders. DDT136000 Rev. 004...
  • Page 3 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.
  • Page 4 - 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.

  • Page 5: Table Of Contents

    System Specifications ......................... 29 ® CritiCool Technical Specifications ..................... 30 ™ CliniLogger Technical Specifications ....................32 CHAPTER 3: INSTALLATION ......................33 Pre-installation Requirements ......................33 Space and Environmental Requirements .................... 33 DDT136000 Rev. 004 Belmont Medical Technologies Page 5 of 125...
  • Page 6 Temperature Probe Sockets ....................... 39 Patient Thermoregulation – Step by Step Operation ................40 Operating the System ......................... 41 Connecting the Water Hoses (Tubes) to CritiCool ................43 Inserting and Attaching Temperature probes ..................44 Activating the System ......................... 45 Wrapping the Patient ..........................
  • Page 7 Converting to Excel ........................... 120 Ending a Viewing Session ........................ 121 APPENDIX A: ........................... 122 Belmont Medical Technologies CUSTOMER SERVICE REPRESENTATIVE ........122 APPENDIX B: EMI / EMC Information ....................123 APPENDIX C: WASTE ELECTRICAL & ELECTRONIC EQUIPMENT (WEEE) ........ 125 DDT136000 Rev.
  • Page 8 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 ............
  • Page 9 Figure 59: Example: Modes and Errors Area..................115 Figure 60: Example of Modes and Error Area..................119 Figure 61: Section of Excel Table...................... 120 Figure 62: Section of Graphic Chart....................121 DDT136000 Rev. 004 Belmont Medical Technologies Page 9 of 125...
  • Page 10 Table 16: CritiCool System Technical Alarm Messages Troubleshooting Guide ........ 100 Table 17: CritiCool System/Clinical Messages Troubleshooting Guide ..........101 Table 18: CritiCool “Core Readout Too Low” Safety Message Troubleshooting Guide ...... 102 Table 19: CritiCool System Messages (Notes) (v6.4 Only) Troubleshooting Guide ......103 Table 20: CritiCool Clinical Messages (Notes) Troubleshooting Guide..........

  • Page 11: Chapter 1: Safety Precautions

    Use only sterile water or 0.22 μm filtered water. Sterile water is recommended. ® Do not plug wet probes into the sockets of the CritiCool device. The user should verify that no fluids are present at the skin/wrap interface during the procedure.

  • Page 12: Precautions

    Chapter 1: Safety Precautions 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. Routine care should be taken during long thermoregulation procedures to prevent pressure sores.

  • Page 13: Emc Safety

    , 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.

  • Page 14: Labels

    Chapter 1: Safety Precautions Labels ® CritiCool System Labels ® Figure 1: Label Placement for the CritiCool Device. DDT136000 Rev. 004 Belmont Medical Technologies Page 14 of 125...

  • Page 15: Label Symbols

    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 DDT136000 Rev. 004 Belmont Medical Technologies Page 15 of 125...
  • Page 16 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. DDT136000 Rev. 004 Belmont Medical Technologies Page 16 of 125...

  • Page 17: Chapter 2: System Description

    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.

  • Page 18: Criticool System

    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.

  • Page 19: External Features

    Chapter 2: System Description External Features Front View Figure 2: Front View. DDT136000 Rev. 004 Belmont Medical Technologies Page 19 of 125...

  • Page 20: Side View

    Chapter 2: System Description Side View Figure 3: Side View. DDT136000 Rev. 004 Belmont Medical Technologies Page 20 of 125...

  • Page 21: Rear Panel

    Chapter 2: System Description Rear Panel Figure 4: Rear View. DDT136000 Rev. 004 Belmont Medical Technologies Page 21 of 125...

  • Page 22: Curewrap

    The wrap is durable for up to 120 hours. Replace the wrap if it becomes soiled. Risk of Reuse CureWrap is for single use only. Reuse could lead to cross-contamination and/or irritation. DDT136000 Rev. 004 Belmont Medical Technologies Page 22 of 125...

  • Page 23: Figure 5: Measurements

    Chapter 3: Installation Figure 5: Measurements. DDT136000 Rev. 004 Belmont Medical Technologies Page 23 of 125...

  • Page 24: Selected Wrap Design

    Size Adult Boxes Accessories ® The following accessories are available for use in conjunction with the CritiCool system. Temperature Probes Intended Use Core temperature probes are used to measure the patient’s core temperature. Surface temperature probes are used to measure the patient’s skin temperature, in a location not covered by the wrap.
  • Page 25 (green), and Infant Core 10 FR (gray), and Surface (green). Both core and surface probes must ® be plugged into the CritiCool system. The core temperature probes must be inserted, and the surface temperature probe must be attached to the patient for the system to function properly.

  • Page 26: Figure 6: Disposable Core Temperature Probe Connection

    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 27: Detachable Electric Power Cable & Plug

    Connecting Tubes for Wrap ® Two flexible 2.58 m long connecting tubes connect the wrap with the CritiCool device to enable the flow of water between them. The tubes are supplied as a paired unit with two male Quick Coupling Connectors ®...

  • Page 28: Male Connector For Draining Water Tank

    It can only collect data when connected to CritiCool. It connects to the serial port on the rear of the device either vertically with the grey right angle adapter attached at the bottom, or horizontally, with the adapter removed.

  • Page 29: Temperature Splitter (Optional)

    Chapter 3: Installation Temperature Splitter (Optional) ® The Temperature Splitter is compatible for the CritiCool system using the YSI 400 Series temperature probes. The Temperature Splitter measures the patient’s temperature using a single sensor in the patient and displays the ®...

  • Page 30: Criticool Technical Specifications

    The system is composed of two elements, the CritiCool device and the CureWrap The system is composed of two elements, the CritiCool device and the CureWrap ® ® ® ® The system is composed of two elements, the CritiCool device and the CureWrap The system is composed of two elements, the CritiCool device and the CureWrap ®...
  • Page 31 Conditions 10-90% Wrap Wrap Transport Transport Wrap Wrap Transport Transport Temperature Temperature Conditions Conditions -20°C to 60°C Temperature Temperature Conditions Conditions Humidity Humidity Humidity Humidity Conditions Conditions Conditions Conditions 20-95% DDT136000 Rev. 004 Belmont Medical Technologies Page 31 of 125...

  • Page 32: Clinilogger ™ Technical Specifications

    . . . Hardware Hardware Hardware Hardware ® Connector Connector Connector Connector DB9 connector for serial interfacing to CritiCool or general PC Size Size 35 x 65 mm Size Size Controller Controller MSP4301611 Micro controller with the following Controller...

  • Page 33: Chapter 3: Installation

    Further, to avoid electromagnetic interferences, it should be no less than 30 cm (11.8”) from equipment emitting electromagnetic frequencies. (See page 123). ® The following dimensions should be considered when placing the CritiCool system: 260 mm W x 625 mm D x 940 mm H / (10.23”W x 24.6”D x 37”H)

  • Page 34: Unpacking And Inspection

    NOTE: Report any container damage prior to opening the container, or any unit damage prior to unpacking, installation, or testing to your Belmont Medical Technologies distributor. Unpacking CritiCool from the Box Follow the instructions shown here to properly unpack CritiCool. Be sure to keep the packaging. DDT136000 Rev. 004 Belmont Medical Technologies...

  • Page 35: Assembling The Handle

    Figure 8: Handle Assembly. Moving the Unit Preparation: Before moving the unit: ® Ensure that the CritiCool system is off by pressing the ON / OFF switch. Ensure that all electrical connections are disconnected. Locking and Unlocking the Trolley Wheels ®...

  • Page 36: Packing Criticool For Shipment

    Chapter 3: Installation Packing CritiCool for Shipment Please follow these instructions to properly prepare CritiCool for transport. Empty the water tank prior to packing CritiCool. DDT136000 Rev. 004 Belmont Medical Technologies Page 36 of 125...

  • Page 37: Chapter 4: Operating Instructions

    Normothermia • CritiCool starts up in one of two patient modes, Adult or Neonatal, depending on the chosen settings. The default settings are different for these two modes. Both can be set by the user per the protocol used at each hospital. The user should set the appropriate patient mode in Settings when setting up the machine.

  • Page 38: Controls, Functions, Indicators And Connections

    Controls, Functions, Indicators and Connections Main Power Switch ® The main power switch, located at the rear of the unit, switches the CritiCool system ON and OFF. The self-test panel is displayed (See page 41). At the end of the Self-Test, an alarm is automatically activated.

  • Page 39: Qcc- Quick Coupling Connectors

    The Water In Quick Coupling Connector on the left (green) • Temperature Probe Sockets ® There are two temperature probe sockets located at the front of the CritiCool device above the Quick Coupling Connectors: Core – for the core temperature probe or adapter cable (gray) •...

  • Page 40: Patient Thermoregulation - Step By Step Operation

    Patient Thermoregulation – Step by Step Operation NOTE: Ambient temperature and other environmental factors can affect thermoregulation with CritiCool. Other devices used with the patient as well as room temperature may need to be adjusted to reduce the impact on thermoregulation with CritiCool.

  • Page 41: Operating The System

    ® NOTE: The Self-Test will occur only if the CritiCool system has been shut off for at least ten minutes. If you wish to use the system after it has been shut off for less than ten minutes, the system will start up in the last screen it was in.

  • Page 42: Figure 10: Halt Error

    Following a successful Self-Test, the system automatically starts to cool the water through internal circulation (as in Standby Mode). NOTE: When using CritiCool to warm a patient or maintain normothermia, it is highly recommended to fully set up CritiCool and the patient probes before ®...

  • Page 43: Connecting The Water Hoses (Tubes) To Criticool

    Water Out. Verify that the tubes are locked by lightly tugging them towards you. Connect water tubes to the wrap and to CritiCool, listening for a click upon each connection. Open the clamps on the wrap, if necessary.

  • Page 44: Inserting And Attaching Temperature Probes

    Chapter 4: Operating Instructions Inserting and Attaching Temperature probes ® WARNING!!! For proper use of the CritiCool system, the core temperature probe must be inserted, and the surface temperature probe must be attached to the patient per the probes’ instructions for use. The location of the surface temperature probe is a clinical decision.

  • Page 45: Activating The System

    Set Point. Figure 12: Main Screen ® Once CritiCool 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.

  • Page 46: Wrapping The Patient

    Chapter 4: Operating Instructions ® The CritiCool system is now operational and preparing itself for the start of therapeutic treatment. NOTE: Confirm that the Patient Mode shown to the left of the Menu button indicates the desired Patient Mode (either Adult or Neonatal).

  • Page 47: The Control Panel

    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 DDT136000 Rev.

  • Page 48: Patient Mode

    The Patient Mode affects alarm conditions as well as the default set point. Patient Mode is designated by one of two icons: Adult Mode: Neonatal Mode: To adjust the Patient Mode, press Menu A list of options appears. DDT136000 Rev. 004 Belmont Medical Technologies Page 48 of 125...

  • Page 49: Figure 14: Settings Screen 1

    A message “Patient Mode Changed. Check Set Point” will appear and remain on the screen for 30 seconds (Software version 6.4 only). Figure 15: Patient Mode Changed. Check Set Point. The set point should always be confirmed after changing the patient mode. DDT136000 Rev. 004 Belmont Medical Technologies Page 49 of 125...
  • Page 50 You will be asked to enter the passcode, which can be found in the manual under Settings on page 57. Enter the code and then press OK. Settings Screen 1 will appear. DDT136000 Rev. 004 Belmont Medical Technologies Page 50 of 125...
  • Page 51 Core Temperature is below 30.8°C. NOTE: Adult Mode triggers different responses than Neonatal Mode. See page 102 for more detail. DDT136000 Rev. 004 Belmont Medical Technologies Page 51 of 125...

  • Page 52: The Main Menu

    When you touch the Menu icon , a list of options appears. Figure 16: Main Menu. The options include the following: Standby • Mode Select • Temp Graph • Settings • Services • DDT136000 Rev. 004 Belmont Medical Technologies Page 52 of 125...

  • Page 53: Standby Mode

    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. To go to Standby:...

  • Page 54: Mode Select

    Touch the required mode icon. The selected mode will be highlighted in blue. Touch OK to activate the mode. NOTE: The selected mode is shown at the top of the control panel (see “the Control Panel”). DDT136000 Rev. 004 Belmont Medical Technologies Page 54 of 125...
  • Page 55 Normothermia mode is for quickly reaching a normal body temperature. Adult/Neonatal setting does not impact operation in Normothermia Mode. NOTE: Normothermia Mode has a default set point of 37.0°C. Normothermia Mode is described in further detail on page 73. DDT136000 Rev. 004 Belmont Medical Technologies Page 55 of 125...

  • Page 56: Temperature Graph

    Move forward or backward the time of the graph displayed by using the arrow keys. The screen can show 1 hour, 6 hours, 12 hours or 24 hours. Use the double arrows to select the time range. DDT136000 Rev. 004 Belmont Medical Technologies Page 56 of 125...

  • Page 57: Settings

    • Language ❷ • Default Set Point Temperature for Adult TTM Mode ❸ • Temperature Scales (Celsius/ Fahrenheit) ❹ • Rewarming Rate Per Hour for Controlled Rewarming Mode ❺ • DDT136000 Rev. 004 Belmont Medical Technologies Page 57 of 125...

  • Page 58: Figure 22: Settings Screen 2

    Low Patient Temperature ❷ • High Water Temperature ❸ • Settings Screen 3 Figure 23: Settings Screen 3 Setting Screen 3 offers the ability to turn off the touch screen. DDT136000 Rev. 004 Belmont Medical Technologies Page 58 of 125...

  • Page 59: Services

    NOTE: Touching the ESC soft key returns to the main screen without saving any changes. Services The Services option is in the Menu panel. Services include the following: Empty • System Check • Technician • Thermal Disinfection • Figure 25: Service Menu DDT136000 Rev. 004 Belmont Medical Technologies Page 59 of 125...

  • Page 60: Figure 26: Start Emptying Panel

    This service allows emptying the system of the remaining water, prior to storing ® CritiCool . Before storing CritiCool, NaDCC should be circulated. See CHAPTER 6: MAINTENANCE. To empty the water tank: In an area away from patient care, with the system powered off, tightly clamp and then disconnect the wrap from the connecting water tubes.

  • Page 61: Figure 27: Emptying Water - Performing Panel

    Water In, not Water Out. See below. Figure 28: Check Water Tubes The Water Out socket is indicated by the gray indicator with an arrow pointed down. DDT136000 Rev. 004 Belmont Medical Technologies Page 61 of 125...

  • Page 62: Modes Of Operation

    Modes of Operation Targeted Temperature Management (TTM) Mode ® Upon startup, the CritiCool system prompts the user to confirm the mode, and an audio alarm sounds. TTM is highlighted by default. When a mode is selected, a default Set Point (SP) temperature appears on the Main Screen.
  • Page 63 When finished, touch OK. ® After adjusting the set point, the CritiCool system automatically operates at the optimal level to obtain the desired set point temperature. The set point should therefore be set upon mode selection and not changed until the patient needs to be rewarmed or there is another need to change the desired patient temperature.
  • Page 64 Controlled Rewarming Mode This mode is used for slow, gradual rewarming following TTM. In Controlled Rewarming Mode, CritiCool increases the set point automatically in small steps until it reaches a normothermic target temperature. In this mode, the normothermic goal temperature is displayed as Target Temperature.
  • Page 65 It would not be unusual if a patient warmed more in one period and less in another, as the algorithm compensates based on actual patient temperature, adjusting for multiple factors. DDT136000 Rev. 004 Belmont Medical Technologies Page 65 of 125...

  • Page 66: Figure 29: Select Mode Controlled Rewarming

    It may take up to two minutes for the values to stop fluctuating. Once the core temperature appears stable, touch OK to start the rewarming process. DDT136000 Rev. 004 Belmont Medical Technologies Page 66 of 125...
  • Page 67 NOTE: If “OK” is pressed before repositioning the probe or before values stabilize, an inaccurate core temperature may be used to calculate the Rewarming Virtual Set Point (RVSP). ® Controlled Rewarming Mode has now begun. CritiCool continues circulation. Confirm the patient core and skin temperatures shown on the screen appear accurate.

  • Page 68: Figure 31: Target Temperature Setting Panel

    Chapter 4: Operating Instructions Figure 31: Target Temperature Setting Panel Touch OK to confirm. Target Temperature should now be displayed correctly. DDT136000 Rev. 004 Belmont Medical Technologies Page 68 of 125...

  • Page 69: Figure 32: Holding Core Temp For First Step Of Rewarming

    NOTE: If a power outage occurs when using Controlled Rewarming Mode, the user should reinitiate Controlled Rewarming Mode, then check that the parameters are correct. If incorrect, adjust parameters and then reinitiate Controlled Rewarming Mode. See page 71 for instructions. DDT136000 Rev. 004 Belmont Medical Technologies Page 69 of 125...

  • Page 70: Figure 33: Target Temperature Has Been Reached

    ® CritiCool continues to maintain the body temperature according to the target temperature. If done thermoregulating with CritiCool, refer to page 89 for instructions on • preparing CritiCool for storage. If continued thermoregulation is desired, Normothermia Mode should be •...

  • Page 71: Figure 34: Temperature Regulation Paused Message

    When monitoring the patient or anytime the core probe dislodges from the patient, check the core probe, then consult the CritiCool screen and compare Core temperature against Next Step.
  • Page 72 In version 6.4, it will also result in holding the core temperature for the next step of rewarming. Rewarm the patient manually by using TTM Mode. (See Manual Rewarming on page 73). DDT136000 Rev. 004 Belmont Medical Technologies Page 72 of 125...

  • Page 73: Normothermia Management

    The set point step and the duration of each step depend on hospital protocol. ® When choosing small steps, CritiCool will keep water temperature close to body temperature. It is recommended to choose steps of 0.1°C – 0.25°C per 30 minutes during the rewarming phase.

  • Page 74: Figure 36: Normothermia Mode

    NOTE: The icons provide a change of 0.1°C. Each scale mark in the toolbar provides a change of 1°C. Exceeding the Normothermia Range If the desired set point temperature is set outside of the normothermia range, the message OUT OF NORMOTHERMIA appears. DDT136000 Rev. 004 Belmont Medical Technologies Page 74 of 125...

  • Page 75: Replacing The Wrap

    Velcro strips (follow the Instructions for Use leaflet supplied with each wrap). 11. 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. DDT136000 Rev. 004 Belmont Medical Technologies Page 75 of 125...

  • Page 76: Operation Panel Messages And Alerts

    If any of the above conditions is not fulfilled, the operation panel message area displays technical and/or clinical alarm messages with a triangular sign NOTE: During safety messages, thermoregulation stops. DDT136000 Rev. 004 Belmont Medical Technologies Page 76 of 125...

  • Page 77: Ttm Mode Messages

    Δ≤ 0.6°C. Figure 39: Low Core Temperature Message. C. Core temperature is lower than the Set Point by 2°C or more (Δ (Tsp- Tcore)> 2°C) or if Tc < 30.8°C DDT136000 Rev. 004 Belmont Medical Technologies Page 77 of 125...

  • Page 78: Figure 40: Ttm Mode: Core Readout Too Low Message

    If the user presses OK but does not resolve the issue, the alarm will sound again in 30 minutes. If the issue is resolved without user involvement, this alarm will resound when conditions are met, regardless of whether 30 minutes has passed. DDT136000 Rev. 004 Belmont Medical Technologies Page 78 of 125...

  • Page 79: Figure 41: Thermoregulation Is Continuing Message

    When OK is touched, the screen returns to the main screen and the following message appears for 5 seconds. Figure 41: Thermoregulation is Continuing Message. This message indicates that water is now flowing into the wrap and that thermoregulation is continuing. DDT136000 Rev. 004 Belmont Medical Technologies Page 79 of 125...

  • Page 80: Controlled Rewarming Mode Messages

    An audible alarm sounds, and the following message appears: Figure 42: Controlled Rewarming Mode: Core Readout Too Low Message. Pressing MUTE disables the audible tone. The alarm restarts after 5 minutes. DDT136000 Rev. 004 Belmont Medical Technologies Page 80 of 125...

  • Page 81: Figure 43: Thermoregulation Is Continuing Message

    When OK is touched, the screen returns to the Main Screen and the following message appears for 5 seconds. Figure 43: Thermoregulation is Continuing Message. DDT136000 Rev. 004 Belmont Medical Technologies Page 81 of 125...

  • Page 82: Chapter 5: Ordering Information

    Medical Technologies representative or your local authorized distributor. When ordering parts, specify the part number as listed in this chapter as well as the serial ® number of your CritiCool system. Available Wraps odels for various wraps are available. Refer to Table...

  • Page 83: Available Accessories

    Chapter 5: Ordering Information Available Accessories One accessory kit is provided with each system. The CritiCool Accessory Kit is available in four configurations: two with reusable temperature probes (PN# 200- 00300 and PN# 200-00320) as shown in Table and Table...

  • Page 84: Table 8: Criticool Infant Disposable Accessory Kit (Pn# 200-00330)

    Chapter 5: Ordering Information Table 8: CritiCool Infant Disposable Accessory Kit (PN# 200-00330) Sub Part No. Description Number Supplied 014-00028 Adapter Cable for Disposable Core Temperature Probe, Gray 014-00129 Adapter Cable for Disposable Surface Temperature Probe RJ, Green 200-00109 Connecting Water Tubes 2 by 2 Way...

  • Page 85: Table 10: Accessories

    Reusable Core Temperature Probe Adult, Gray (12FR) 014-00021 Reusable Surface Temperature Probe, Green 014-00028 Adapter Cable for Disposable Core Temperature Probe YSI 400, Gray 014-00129 Adapter Cable for Disposable Surface Temperature Probe RJ, Green DDT136000 Rev. 004 Belmont Medical Technologies Page 85 of 125...

  • Page 86: Chapter 6: Maintenance

    Trained 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. Service Information When communicating with authorized Belmont Medical Technologies ®...

  • Page 87: Routine Maintenance

    Chapter 6: Maintenance Routine Maintenance ® The CritiCool system should be inspected and maintained as noted in Table 11 to make sure that it remains in optimum condition. Table 11: Inspection and Maintenance Schedule Frequency Inspection/Service Performed • Clean connecting tubes and Quick Coupling...

  • Page 88: Routine Maintenance Overview

    Recommended Disinfectants for External Surfaces Chlorinated bleach solution (5.25% sodium hypochlorite concentration) • Quaternary ammonium compounds (ammonium chloride as active ingredient) • ® Germicidal Disposable Wipes (Sani-Cloth or equivalent) • DDT136000 Rev. 004 Belmont Medical Technologies Page 88 of 125...

  • Page 89: Before Each Use

    NaDCC to use. A full water tank (six liters or 1.6 gallon) allows for optimal cleaning of the CritiCool water tank. Add sterile water (or 0.22 micron filtered water) as needed. For a full CritiCool water tank, eight 13.1g NaDCC tablets are needed.

  • Page 90: Thermal Disinfection (Self-Cleaning)

    This feature performs a thermal disinfection of the water tank and internal tubing. ® The thermal disinfection of CritiCool is an integrated feature, which heats the circulating water of the system, thus allowing the heat to disinfect the internal water pathways of the system, including the water tank.

  • Page 91: System Check Service

    • Temperature of water inflow and water outflow • ® Successful completion of the system check service indicates that the CritiCool system is operational. ® NOTE: If the CritiCool was out of use for a long time, a full System Check should be performed.

  • Page 92: Filter Replacement

    The filter is for filtering hard soils or large particles. It is not intended for filtering the water from bacterial contamination. The filter must be replaced every twelve months at a minimum. NOTE: The filter should be replaced only by Belmont Medical Technologies authorized personnel. See the Service Manual for replacement instructions. DDT136000 Rev. 004...

  • Page 93: Chapter 7: Troubleshooting

    Chapter 7: Troubleshooting CHAPTER 7: TROUBLESHOOTING General ® The CritiCool system is equipped with self-testing routines that continuously monitor system operation. If a system fault or malfunction is detected, a fault message appears. Should a malfunction occur, consult the Troubleshooting Guide.

  • Page 94: Table 12: Criticool System Malfunction (No Message) Troubleshooting Guide

    WARNING!!! The repair and servicing of the CritiCool system should be performed only by Belmont Medical Technologies or authorized agents of Belmont Medical Technologies. Table 12: CritiCool System Malfunction (no message) Troubleshooting Guide Observation Possible Problem Action to be Taken ®...
  • Page 95 ESC to return to the prior unhighlighted after 10 operating mode. seconds. NOTE: A muted alarm is activated when a subsequent message appears. DDT136000 Rev. 004 Belmont Medical Technologies Page 95 of 125...

  • Page 96: Table 13: Criticool Controlled Rewarming Mode Troubleshooting Guide

    Chapter 7: Troubleshooting Table 13: CritiCool Controlled Rewarming Mode Troubleshooting Guide Observation Possible Problem Action to be Taken The rewarming rate “Next Step” displayed on Reinitiate Controlled was changed when the screen does not seem Rewarming. Press Menu, using Controlled...
  • Page 97 Select, Normothermia temperature differs from the temperature, target Mode, OK. Verify the set target temperature by temperature is point temperature and considered to have been ≤0.3°C. adjust if needed. reached. DDT136000 Rev. 004 Belmont Medical Technologies Page 97 of 125...

  • Page 98: Figure 46: Male Draining Connector Attached To Connecting Water Hoses (For Emptying)

    Chapter 7: Troubleshooting Table 14: Draining CritiCool / Water Tank Overfilled Observation Action to be taken Water tank It is necessary to drain the water tank after each use: overfilled. Connect one connecting tube to the right quick coupling connector.

  • Page 99: Table 15: Criticool System Technical Alarm Messages Troubleshooting Guide

    Chapter 7: Troubleshooting Table 15: CritiCool System Technical Alarm Messages Troubleshooting Guide Action to Message Cause of Comments be taken Problem Indicates that an alarm is activated Tank is Empty No water in the Open water tank. tank cap. Refill water...

  • Page 100: Table 16: Criticool System Technical Alarm Messages Troubleshooting Guide

    Chapter 7: Troubleshooting Table 16: CritiCool System Technical Alarm Messages Troubleshooting Guide Action to be Message Cause of Comments taken Problem Connect Core Sensor No core Connect core Pressing alarm temperature temperature mute silences probe is probe. the buzzer for inserted in its 30 minutes.

  • Page 101: Table 17: Criticool System/Clinical Messages Troubleshooting Guide

    Chapter 7: Troubleshooting Table 17: CritiCool System/Clinical Messages Troubleshooting Guide Message Cause of Action to be Comments Problem taken Water Temperature Water Thermoregulation The alarm can be Too Low temperature in stops. muted for the system is Turn OFF the unlimited time.

  • Page 102: Table 18: Criticool "Core Readout Too Low" Safety Message Troubleshooting Guide

    Chapter 7: Troubleshooting Table 18: CritiCool “Core Readout Too Low” Safety Message Troubleshooting Guide Action to be Message Cause of Comments taken Problem TTM Mode and Controlled Rewarming Mode: Core Readout Too Low Core Confirm the An alarm sounds, temperature is...

  • Page 103: Table 19: Criticool System Messages (Notes) (V6.4 Only) Troubleshooting Guide

    Chapter 7: Troubleshooting Table 19: CritiCool System Messages (Notes) (v6.4 Only) Troubleshooting Guide Action to be Message Cause of Comments taken Problem Patient Mode Changed. The patient Confirm Set This message Check Set Point. mode has been Point and adjust...

  • Page 104: Table 20: Criticool Clinical Messages (Notes) Troubleshooting Guide

    Chapter 7: Troubleshooting Table 20: CritiCool Clinical Messages (Notes) Troubleshooting Guide Message Cause of Problem Action to be Comments taken Low Core Temperature This message Check core An alarm sounds Thermoregulation is appears: temperature Continuing. probe is in thermoregulation place and continues.

  • Page 105: Table 21: Criticool Clinical Messages (Notes) Troubleshooting Guide

    Chapter 7: Troubleshooting Table 21: CritiCool Clinical Messages (Notes) Troubleshooting Guide Message Cause of Action to Comments Problem be taken Patient Temperature is The alarm for Check that An alarm sounds Above XX.X°C High Patient the core but thermoregulation Temperature temperature continues.

  • Page 106: Chapter 8: Clinilogger Installation And Operating Instructions

    CliniLogger Viewer software CD to be ® installed on a PC for downloading and viewing the saved data from the CritiCool Alternatively, to download the software online, request the link from the Belmont technical service team at techservice@belmontmedtech.com.

  • Page 107: Figure 47: Clinilogger™ Initialization

    When initialization finishes the following screen appears. ™ Figure 48: CliniLogger Installation. You can change the installation location by clicking Browse and selecting a new location. Click Next. The License Agreement window appears. DDT136000 Rev. 004 Belmont Medical Technologies Page 107 of 125...

  • Page 108: Figure 49: Start Installation

    Next. The Start Installation window appears. Figure 49: Start Installation. Click Next; you can follow the installation progress in the progress bars until it finishes. Figure 50: Installation Progress. DDT136000 Rev. 004 Belmont Medical Technologies Page 108 of 125...

  • Page 109: Figure 51: Installation Complete

    Click Finish to complete and exit the software installation. Copy "User Ver 1.6" 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. DDT136000 Rev. 004 Belmont Medical Technologies Page 109 of 125...

  • Page 110: Using The Clinilogger Viewer Application

    COM 1 –10 port or you can use with USB to RS232 adaptor. Click Connect to Logger, the software traces the COM port where the ™ CliniLogger is connected – wait for the message. DDT136000 Rev. 004 Belmont Medical Technologies Page 110 of 125...

  • Page 111: Viewing Downloaded Data

    To view downloaded data: ™ ™ Double-click the CliniLogger Viewer icon. The CliniLogger window appears. ™ Figure 53: CliniLogger Window. Click Load stored data and choose the file you would like to view. DDT136000 Rev. 004 Belmont Medical Technologies Page 111 of 125...

  • Page 112: Figure 54: Choose Clinilogger

    When the data has been loaded the “Complete” message appears Figure 55: Complete Message. Click View data - the graph opens. To convert to Excel, click Convert to Excel – the data is presented in Excel format. DDT136000 Rev. 004 Belmont Medical Technologies Page 112 of 125...

  • Page 113: Clinilogger ™ Viewing Panel

    Start time and Date Figure 56: CliniLogger™ Viewing Panel. ™ The CliniLogger viewing panel includes the following data: ® Start date and time received from the thermoregulation device (CritiCool • Software version of the thermoregulation device • Close Window button •...

  • Page 114: Figure 57: 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 • DDT136000 Rev. 004 Belmont Medical Technologies Page 114 of 125...

  • Page 115: Figure 58: Example: Functional Status Area

    Temperature Settings Wrap Settings Errors/TempStep Settings Figure 59: Example: Modes and Errors Area. Temperature graph control buttons enable modifying the display of each of the temperature graphs. DDT136000 Rev. 004 Belmont Medical Technologies Page 115 of 125...
  • Page 116 Moving the mouse horizontally will move the graphs horizontally - in time, and moving the mouse vertically, will move the graphs vertically - in temperature. Zoom Clicking the Zoom button shows 6 modes of zoom use: DDT136000 Rev. 004 Belmont Medical Technologies Page 116 of 125...

  • Page 117: Table 22: Zoom Tool Buttons

    To return to full time scale after zoom actions: Click on The graph returns to the full-time range, without affecting the Temperature scale. NOTE: To return to the original display click the unzoom button DDT136000 Rev. 004 Belmont Medical Technologies Page 117 of 125...
  • Page 118 Use the mouse to move the double line to a new cursor location. NOTE: The values of the temperature at the cursor location appear in the window adjacent to the curve color window DDT136000 Rev. 004 Belmont Medical Technologies Page 118 of 125...

  • Page 119: Figure 60: Example Of Modes And Error Area

    PowerUp Rewarm Neonate PowerUp Standby PowerUp Sel.Mode Adult PowerUp Sel.Mode Neonate Cooling Adult Cooling Neonate Warming Adult Warming Neonate Rewarming Adult Rewarming Neonate Standby Select Mode Adult Select Mode Neonate DDT136000 Rev. 004 Belmont Medical Technologies Page 119 of 125...

  • Page 120: Converting To Excel

    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. When the device is warming the water in the tank, the line is red.

  • Page 121: Ending A Viewing Session

    Y axis showing the temperatures, and the X axis the Excel table lines. Figure 62: Section of Graphic Chart. Ending a Viewing Session To end a session: Click Quit on the Main Menu to exit the Viewing Session DDT136000 Rev. 004 Belmont Medical Technologies Page 121 of 125...

  • Page 122: Belmont Medical Technologies Customer Service Representative

    PPENDIX Belmont Medical Technologies C USTOMER ERVICE EPRESENTATIVE 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:...

  • Page 123: Appendix B: Emi / Emc Information

    Environment of use to permit the Equipment or System to perform its intended use without disturbing other Equipment and Systems or non-medical electrical equipment. The essential performance features of CritiCool are the accuracy of the temperature measurement system, the water temperature control, alarms if core temperature is unexpected, and halt conditions in case that any of the elements of the control mechanism fail.

  • Page 124: Table 25: Guidance And Manufacturer's Declaration - Immunity

    Table 25: Guidance and Manufacturer’s Declaration – Immunity ® CritiCool is intended for use in the electromagnetic environment specified below. ® The customer or user of CritiCool should assure that it is used in such an environment. Immunity Test IEC 60601 Passed Parameters IEC 61000-4-2 ±8kV contact...

  • Page 125: Appendix C: Waste Electrical & Electronic Equipment (Weee)

    DDT136000 Rev. 004 Belmont Medical Technologies Page 125 of 125...

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