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Belmont Medical Technologies CRITICOOL Operational Training

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CRITICOOL
6.3
OPERATIONAL
TRAINING
701-00235 Rev. C
This presentation will provide operational training for CritiCool.
1

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  • Page 1 ® CRITICOOL OPERATIONAL TRAINING 701-00235 Rev. C This presentation will provide operational training for CritiCool.
  • Page 2 Indication for Use – CritiCool is a thermal regulating system, indicated for monitoring and controlling patient temperature © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C CritiCool is designed to regulate body temperature as determined by the physician.
  • Page 3 CureWrap CureWrap CureWrap CureWrap ® ® ® ® Garments Garments Garments Garments CritiCool CritiCool Control Unit Control Unit 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only CritiCool is used in conjunction with CureWrap garments.
  • Page 4 SIMPLE. PRECISE. EFFECTIVE. © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C CritiCool makes it easy to manage thermoregulation.
  • Page 5 Every 0.133 seconds © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C CritiCool reads the patient’s core temperature through specific probes every 133 milliseconds and adjusts temperature as necessary in order to maintain the physician determined pre-set temperature settings.
  • Page 6 Quick and easy set up Quick and easy set up • Track Track data using the CliniLogger™ Track Track © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C CritiCool is known for offering precise, simple and effective temperature control.
  • Page 7 SIMPLE, EASY TO USE INTERFACE SIMPLE, EASY TO USE INTERFACE SIMPLE, EASY TO USE INTERFACE SIMPLE, EASY TO USE INTERFACE © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C This slide provides an idea of the simplicity of the user interface.
  • Page 8 Core sensor socket Water in coupling Water in coupling connector connector Water out coupling connector Water level Water level indicator indicator © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C Here is a diagram of the front of CritiCool.
  • Page 9 © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C Here is the back of CritiCool, and here is where the CliniLogger is plugged in. When plugged in, the CliniLogger records procedural data (times and temperatures) and allows for exporting case data.
  • Page 10 2.030 /1.354 Pediatric Infant © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only These are the different wrap configurations available. There are three boxes that offer eight wraps of the same size, and then there are four pediatric assorted boxes that offer eight...
  • Page 11 SETTING UP CRITICOOL 701-00235 Rev. C Let’s go over how to set up CritiCool.
  • Page 12 © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C This shows how to unpack CritiCool from the box. The handle and accessory kit will be visible when you first open the box, and then you’ll remove the box on top, and then slide the outer box upwards.
  • Page 13 UNPACKING CRITICOOL © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C Removing the foam will reveal CritiCool on its side in a protective bag. Set the device on its wheels carefully and then slide in the handle.
  • Page 14 Place the CritiCool unit near the bed and lock the front wheels 2. Fill tank with sterile water or 0.22 micron filtered water – The largest CureWrap 500-03500 requires 6L (up to the red line on the water level indicator).
  • Page 15 CureWrap is sold in boxes of 8; see slide 10. 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Select a wrap for the case, and lay it on the bed, with the tubes at the head of the bed, with the tubing hanging off the bed a few inches.
  • Page 16 Surface Disposable Adapter Cable © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only – 701-00235 Rev C Choose the appropriate probe. A reusable probe can be used by itself (see left side), or a disposable temperature probe can be connected to a temperature adapter cable (right side).
  • Page 17 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only If using disposable probes, plug the adapter cable into CritiCool, matching colors, green to green for the surface cable, and gray to gray for the core cable.
  • Page 18 Control Unit Patient 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Connect the probes into the adapter cables, matching connections, the RJ phone jack connection for surface, and the molex YSI 400 connection for core.
  • Page 19 – Neonates: often by clavicle – 014-00321 Please review all indications and contraindications for each probe prior to use. 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Core probes can be inserted into the patient’s rectum or esophagus.
  • Page 20 appropriate use.
  • Page 21 CORE CORE readout – Therefore, water will not flow into CureWrap until the core probe is connected to CritiCool and the core probe is attached to the patient 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only The core temperature is required for the water to flow into the wrap.
  • Page 22 STEP-BY-STEP: SETTING UP CUREWRAP 1. Connect metal fittings on blue hose to metal fittings on the front of CritiCool Water in coupling Water in coupling connector connector Water out coupling connector 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential...
  • Page 23 – Wrap should be filled with water prior to wrapping patient – Ensure clamps are OPEN 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Now connect the hoses to the wrap, connecting plastic to plastic, again listening for a click...
  • Page 24 Water Hoses: 200-00147 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Make sure you have the right hoses for the wrap you’ll need. Adult wraps (part number 500-03500) require the 2x3 way hoses, but 500-03500 is sold in two box configurations, 508-03500 and PED-XL008.
  • Page 25 • PED-XL008 (includes four 500-03500 and four 500- 03548 CureWraps) • 500-03500 has 3 connectors to the CureWrap. • The 2x3 Way Hoses are included in all Adult Accessory Kits or can be ordered separately. © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C...
  • Page 26 500-03500. • All wraps except 500-03500 have 2 connectors to the CureWrap. • The 2x2 Way hoses are included in all Infant Accessory Kits or can be ordered separately. © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C...
  • Page 27 STEP BY STEP: TTM – SETTING UP CRITICOOL 1. After self test is complete, the start up Mode Select screen appears. 2. Push OK OK to select TTM TTM mode (default Mode) 3. CritiCool is now cooling and circulating the water internally...
  • Page 28 If required, change the SP temperature by using the Set Point soft key on the screen 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Now we can make sure the set point, or target temperature of the patient, is where we want it.
  • Page 29 ○ Check to ensure the clamps are open and water is allowed to flow to CureWrap and that water is flowing 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Now that the wrap has filled with water, the patient can be wrapped according to the CureWrap instructions for use (IFU).
  • Page 30 SECURING THE CUREWRAP AROUND THE PATIENT © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C This video shows how to secure CureWrap around the patient.
  • Page 31 SECURING THE CUREWRAP AROUND THE PATIENT Model 500-03500 CureWrap shown 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only These images show how to correctly wrap a position with the 3500 model CureWrap.
  • Page 32 © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C CritiCool and the patient is now fully set up. This is the main operation screen that you’ll see. [Boxes around Menu, Temp Graph and Set Point Key are links to the corresponding slides –...
  • Page 33 • Power soft key • © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C The touch screen is shown on the left and the soft button keys are shown on the right. If the touch screen is ever turned off, the soft button keys will need to be used. If muting an alarm, press the alarm tone ON/OFF soft button key;...

  • Page 34: Menu Options

    Once the Menu drop down ESC icon appears, touch it to return to previous screen © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C The main menu is found in the top right corner of the screen. Here are the options:...
  • Page 35 SELECT SET POINT TEMPERATURE Set Point = Patient’s Target Temperature • The CritiCool cools/warms the patient to reach and maintain the preset Set Point • TTM default set-point: – 33.0°C for Adult Mode – 33.5°C for Neonatal Mode • To change the Set Point: 1.

  • Page 36: Temperature Graph

    Press the temperature graph button (bar chart icon) to view the procedural data graphically. Case data is always saved until the next patient is connected to CritiCool. On the X axis, you’ll see time. You can view time in different increments (1h, 6h, 12h or 24h), and you can use the arrows to view the beginning or end of the case.
  • Page 37 • Password for the Settings Screen: ____ ( Enter once trained; See slide 38) 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only A password is needed to access the Settings Menu: 6873. It is needed to change default set temperature, adjustable alarms, the rewarming step, and more.
  • Page 38 Four Screens in the Settings mode • Push to confirm and return to main screen • The CritiCool keeps the last setting to the next power up The default/last selection is highlighted • Screen #1 – General Settings Screen #2 – Setting Alarm Limits ©...
  • Page 39 SETTINGS SCREEN – PASSWORD PROTECTED Screen #3 – Touch Screen ON/OFF Screen #4 – Set Date and Time © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C Access Setting Screen 3 by pressing the 3 on the right side of the screen.

  • Page 40: Standby Mode

    Internal Use Only Standby Mode is used to stop water flow to the wrap. During Standby, as shown in the screen on the bottom right, there is no thermoregulation or water flow. CritiCool will only monitor temperature when in Standby Mode.

  • Page 41: Select Mode

    3. Touch the desired mode 4. Touch to confirm 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only If you wish to change the mode, press Menu, then Mode Select, then OK to change the mode.
  • Page 42 – To reach a preset set point – To maintain patient temperature – For manual re-warming © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C TTM is the default mode and should be using for cooling followed by rewarming, to maintain a temperature, or for manual rewarming.
  • Page 43 2. Push OK to confirm Core temperature probe is in place and start the rewarming process © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C Controlled Rewarming is used when controlled rewarming after cooling is preferred.
  • Page 44 Settings. Next Step (shown at the top) indicates the next goal temperature on the gradual climb to the target temperature. If CritiCool finds that the patient is rewarming too slowly or quickly, it will automatically adjust in the next step.
  • Page 45 – It has no rewarming steps – Algorithm aims to bring patient to the target temperature as quickly as possible • The CritiCool warms the patient to reach and maintain the selected Set Point 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Normothermia mode should not be used after a patient was cooled.

  • Page 46: Maintenance

    MAINTENANCE 701-00235 Rev. C...

  • Page 47: Service Screen

    Reference the Service Manual for further instructions. 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only The service screen is where you can access the emptying cycle, system check, the technician screen, and thermal disinfection. Both Technician and Thermal Disinfection screens require separate passcodes that are only provided to those trained by Belmont or an authorized Belmont distributor to service Belmont equipment.
  • Page 48 © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Here we learn how to drain CritiCool. The drain plug shown in the image comes attached to the end of the blue water connecting hoses PN # 200-00109 and 200-00147.

  • Page 49: Thermal Disinfection

    • Thermal Disinfection is Password Protected – Can only be accessed by a Belmont-trained Biomedical Technician 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only The Thermal Disinfection screen can only be accessed by those trained by Belmont or an authorized Belmont distributor to service Belmont equipment.

  • Page 50: Routine Maintenance

    As part of the annual periodic maintenance, a thermal disinfection cycle will be performed. 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only After each operation: Make sure that the system is turned off. Wait a few moments.
  • Page 51 After cleaning let the system dry for 10 minutes. Annually: Perform periodic maintenance once a year by a Belmont Medical Technologies or authorized trained technician only. As part of the annual periodic maintenance, a thermal disinfection cycle will be performed.

  • Page 52: Messages And Troubleshooting

    MESSAGES AND TROUBLESHOOTING 701-00235 Rev. C...
  • Page 53 MESSAGES & TROUBLESHOOTING The CritiCool uses two types of messages: Error Message Informative Message o Alarm sound o Alarm sound o Error Message screen o Operation screen o Troubleshooting guidelines o Thermoregulation continues o Error icon is on o System function status is on ©...

  • Page 54: Alarm Message

    Operation screen o Thermoregulation continues o System function status is on © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C This alarms sounds when the core temperature is more than 0.8 and less than 2.0 degrees lower than the set point temperature.
  • Page 55 Error icon is on After the user acknowledges the message on the screen, water will once again flow to the wrap and CritiCool will not alarm for that condition for 30 minutes. If after 30 minutes the alarm conditions apply, it will once again stop water flow and alert the user.
  • Page 56 Troubleshooting guidelines o Error icon is on 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only This is the message that appears when switching to Controlled Rewarming. Water flow has stopped. The alarm notes that temperature regulation is paused until the alarm is acknowledged.
  • Page 57 The message will continue until the problem has been resolved. o Error icon is on © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C When the tubes are kinked or the wrap is folded, this alarm might sound. Generally it is at the wrap/hose connection where kinking can cause this alarm to sound.
  • Page 58 © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only CritiCool has a pressure relief algorithm that automatically allows the water to drain from CureWrap automatically. Should a difference of more than 0.3 degrees C between the core temperature and set point temperature be observed, water will immediately flow back into the wrap to adjust the patient’s temperature.
  • Page 59 *After the user acknowledges the message on the screen, water will once again flow to the wrap and CritiCool will not alarm for that condition for 30 minutes. If after 30 minutes the alarm conditions apply, it will once again stop water flow and alert the user.
  • Page 60 Default Set Point: Default Set Point: 33.5°C (Set point temperature range: 30-40°C) • To change the set point: – Press the thermometer key – Choose the desired temperature 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only...
  • Page 61 35.0 or or or or 36.0 36.0 (see #3 at right) 33.0 33.0 34.0 34.0 35.0 35.0 36.0 36.0 – Select OK (Selection will be default in future) 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only...

  • Page 62: Water Temperature Settings

    – CritiCool turns off thermoelectric coolers (TECs) if water temperature >43°C (no water flow) – CritiCool shuts off if water temperature reaches 44°C with Halt 3 (no water flow) 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential...
  • Page 63 Replacements Replacements Connection Type Molex / YSI 400 Surface Cable 014-00029 014-00129 for Disposable Probes Disposable 014-00221 014-00321 Surface Probes © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C The current disposable surface temperature probe is PN# 014-00321.
  • Page 64 © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only CritiCool version 6.3 is the latest version of CritiCool. It began shipping in 2019. Prior versions featured two different alarm sounds, whereas the current version features one buzzer sound. [Play sounds].
  • Page 65 • Colors • Power loss 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Red was removed from all screens in version 6.3. Therefore, alarms that used to flash red triangles now flash black and yellow.
  • Page 66 • Muted alarm icon • Colors • Power loss 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only The Standby Mode Screen now features a blue (not red) banner at the top of the screen.
  • Page 67 6.2 and earlier: • CritiCool Version 6.3 / After July 2020: 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only Version 6.3 now maintains all settings for 10 minutes, whereas prior versions maintained settings for 10 seconds.
  • Page 68 CritiCool Power Supply 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only The temperature splitter is an optional accessory that allows for sharing the patient’s core temperature with an external device. It requires an additional core adapter cable.
  • Page 69 © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C Here is how to pack CritiCool before shipment. Be sure to always ship CritiCool empty. The instructions are found on the box itself. Please always refer to the instructions on the...
  • Page 70 PACKING CRITICOOL FOR SHIPMENT © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential 701-00235 Rev. C...
  • Page 71 PASSCODE FOR SETTINGS SCREEN • Enter into: – Settings section in CritiCool User Manual – Appendix A at the end of the CritiCool User Manual 701-00235 Rev. C © BELMONT MEDICAL TECHNOLOGIES | Proprietary & Confidential Internal Use Only The passcode for the settings screen (6873) should be written into the user manual in two...

  • Page 72: Important Points

    IMPORTANT POINTS • Use sterile water or 0.22 micron filtered water only • The CritiCool cannot thermoregulate without a valid Core readout • CureWrap should be filled with water prior to wrapping and securing on patient • CureWrap should stay one finger loose on the patient •...
  • Page 73 701-00235 Rev. C Please email or call tech support with questions.
  • Page 74 THANK YOU Thank you for learning about CritiCool!

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