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701-00320 Rev. A

CRITICOOL

MINI INDICATION FOR USE

Indication for Use

The CritiCool

MINI is designed

to regulate body temperature
as determined by the
physician.

CritiCool MINI is designed to regulate body temperature as determined by the physician.

Содержание CRITICOOL MINI

Страница 1: ...CRITICOOL MINI OPERATIONAL TRAINING 701 00320 Rev A This presentation will provide operational training for CritiCool MINI 1 ...

Страница 2: ...COOL MINI INDICATION FOR USE Indication for Use Indication for Use Indication for Use Indication for Use The CritiCool MINI is designed to regulate body temperature as determined by the physician CritiCool MINI is designed to regulate body temperature as determined by the physician 2 ...

Страница 3: ...rol Unit Control Unit Control Unit Control Unit CureWrap CureWrap CureWrap CureWrap Garments Garments Garments Garments CritiCool MINI CritiCool MINI CritiCool MINI CritiCool MINI Control Unit Control Unit Control Unit Control Unit CritiCool MINI is part of the CritiCool product family and like CritiCool is used in conjunction with CureWrap garments 3 ...

Страница 4: ...gn Complete Treatment Compact Design Complete Treatment Compact Design Complete Treatment Compact Design Complete Treatment Battery operated Battery operated Battery operated Battery operated thermoregulation device Sized Sized Sized Sized for in hospital transport Advanced and intuitive Advanced and intuitive Advanced and intuitive Advanced and intuitive user interface CritiCool MINI provides adv...

Страница 5: ... 2021 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 5 701 00320 Rev A FAST SIMPLE PRECISE CritiCool MINI makes it easy to manage thermoregulation 5 ...

Страница 6: ...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 Every 133 seconds CritiCool MINI 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 temper...

Страница 7: ...olor touch screen Water level indicator Water level indicator Water in coupling connector Water in coupling connector Water out coupling connector Surface sensor socket Surface sensor socket Core sensor socket Soft bottom keys Soft bottom keys Core out socket Core out socket Here is a diagram of the front of CritiCool MINI 7 ...

Страница 8: ...ial 8 701 00320 Rev A CRITICOOL MINI BACK VIEW CliniLogger Here is the back of CritiCool MINI 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 8 ...

Страница 9: ...nfidential 9 701 00320 Rev A UNPACKING CRITICOOL MINI This shows how to unpack CritiCool MINI from the box The accessory kit will be visible when you first open the box and then you ll remove the foam on each end to reveal the CritiCool MINI device 9 ...

Страница 10: ...m Width m Width m Infant Infant Infant Infant Single Single Single Single Size Size Size Size 508 03518 8 2 5 to 4 kg 5 5 to 8 8 lb 0 659 0 448 508 03521 8 4 7 kg 8 8 15 5 lb 0 698 0 602 Infant Infant Infant Infant Assorted Assorted Assorted Assorted PED SM008 8 multi size x4 x4 2 5 to 4 kg 5 5 to 8 8 lb 4 7 kg 8 8 15 5 lb 0 659 0 448 0 698 0 602 CUREWRAP SELECTING THE WRAP There are three boxes o...

Страница 11: ...701 00320 Rev A SETTING UP CRITICOOL MINI Let s go over how to set up CritiCool MINI 11 ...

Страница 12: ...er ON ON ON ON switch after a short Self Test Mode Select screen appears Remove this cap to fill Remove this cap to fill Power switch Power switch 1 Place the CritiCool MINI unit near the bed 2 Remove the cap to the water tank and fill tank with sterile water or 0 22 micron filtered water 1 2L 3 Power ON the device by holding down the power switch on the right side of the device After a short Self...

Страница 13: ...0 Rev A STEP BY STEP SETTING UP CUREWRAP 1 Place the appropriate CureWrap on the bed or underneath patient Tubes should be at the patient s head See CureWrap Instructions For Use Lay out the wrap on the bed or underneath the patient with the tubes at the patient s head 13 ...

Страница 14: ... Probes only select markets Disposable Temperature Probes United States all markets Core Disposable Adapter Cable Disposable Adapter Cable Surface AND AND 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 14 ...

Страница 15: ...Surface Surface Surface socket SURFACE on left Green color coding CORE on right Gray color coding CORE CORE SURFACE SURFACE The reusable temperature probe can be plugged directly into the CritiCool MINI on the colored end Match colors green to green for the surface probe and gray to gray for the core probe Reusable probes have an expected life of three years Please refer to the manufacturer s inst...

Страница 16: ...ore Core Core socket and Surface Surface Surface Surface cable to the Surface Surface Surface Surface socket SURFACE on left Green color coding CORE on right Gray color coding SURFACE SURFACE CORE CORE If using disposable probes plug the adapter cable into CritiCool MINI matching colors green to green for the surface cable and gray to gray for the core cable 16 ...

Страница 17: ...USING DISPOSABLE PROBES Patient Connect Core sensor to the Core Adapter Cable and the Surface sensor to the Surface Adapter Cable Control Unit Connect the probes into the adapter cables matching connections the RJ phone jack connection for surface and the molex YSI 400 connection for core 17 ...

Страница 18: ...t skin Core Probe Placement Rectal esophageal 014 00005 or 014 00322 Surface Probe Placement Do not place skin sensor under CureWrap Neonates often by clavicle 014 00021 or 014 00321 Core probes can be inserted into the patient s rectum or esophagus Surface probes can be placed on the patient s skin anywhere not covered by the wrap The clavicle is a common location on neonates for the surface prob...

Страница 19: ...e water will not flow into CureWrap until the core probe is connected to CritiCool MINI and the core probe is attached to the patient The core temperature is required for the water to flow into the wrap Therefore you won t be able to fill the wrap until you have in addition to setting up the device hoses and wrap inserted the core probe into the patient and a valid reading is measured 19 ...

Страница 20: ...G UP CUREWRAP Connect metal fittings on blue hose to metal fittings on the front of CritiCool MINI Water out coupling connector Water in coupling connector Water in coupling connector Now connect the hoses to the device as shown here connecting metal to metal and listening for a click each time 20 ...

Страница 21: ...STEP BY STEP SETTING UP CUREWRAP Connect plastic ends of blue connecting water hoses to wrap Ensure clamps are OPEN Wrap should be filled with water prior to wrapping patient Now connect the hoses to the wrap connecting plastic to plastic again listening for a click each time 21 ...

Страница 22: ...select TTM TTM TTM TTM mode default Mode 3 CritiCool MINI is now cooling and circulating the water internally Touch OK to start TTM Touch OK to start TTM Now return to the touch screen on the device The self test will have completed by now and we see that TTM mode is selected which is what we want to use to cool a patient We can press OK Now that everything is connected water will begin to flow in...

Страница 23: ...key on the screen The Default Set Point temperature can be adjusted in Settings Now we can make sure the set point or target temperature of the patient is where we want it The default set point temperature is 33 5 Press the set point key shown here to change the set point for this particular case If you wish to change the default set point you can do so in the Settings menu which will be discussed...

Страница 24: ...id handling the CureWrap with sharp objects Constant clicking sound may indicate water obstruction Check to ensure the clamps are open and water is allowed to flow to CureWrap and that water is flowing Now that the wrap has filled with water the patient can be wrapped according to the CureWrap instructions for use IFU The tubes should be at the head of the bed The wrap should be loose around the p...

Страница 25: ... 2021 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 25 701 00320 Rev A SECURING THE CUREWRAP AROUND THE PATIENT This video shows how to secure CureWrap around the patient 25 ...

Страница 26: ...u Escape Show graph Up Arrow Alarm tone ON OFF Open Settings panel Down Arrow Accept changes Touch Keys 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 it is not possible to mute an alarm using the touch screen 26 ...

Страница 27: ...he Menu Icon Soft Button Key Drop Menu will appear with the following options Once the Menu drop down ESC icon appears touch it to return to previous screen The main menu is found in the top right corner of the screen Here are the options Standby Mode Select Temperature Graph Settings and Services 27 ...

Страница 28: ...e the Set Point 1 Touch the Set Point Icon button 2 Use to select the desired Set Point 3 Press OK OK OK OK to confirm SELECT SET POINT TEMPERATURE Press the set point key shown here thermometer icon to change the set point for this particular case You ll then see a scale where you can adjust in either 1 0 degree increments by pressing a tick mark or by 0 1 increments by pressing the plus or minus...

Страница 29: ...e graph button bar chart icon to view the procedural data graphically Case data is always saved until the next patient is connected to CritiCool MINI 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 Temperature is on the Y axis The surface line can be turned on or off by pressing the Surf bu...

Страница 30: ...ASSWORD PROTECTED Password for the Settings Screen 6873 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 To enter the passcode press Menu then Settings then enter 6873 on the keypad then press OK 30 ...

Страница 31: ...t SP to 33 5 34 0 35 0 or 36 0 4 Adjust Degree measurement view Celsius or Fahrenheit 5 Adjust the Rewarming Step from 0 05 to 0 5 degrees C per hour in 0 05 increments this is only used in Controlled Rewarming Mode Access Setting Screen 2 by pressing the 2 on the right side of the screen The second screen allows you to change adjustable alarm limits 1 An alarm for High Patient Temperature can be ...

Страница 32: ... to set date and time If Celsius is chosen date and time are shown in European Military format DD MM YYYY and HH MM SS Select the digit to change and then use the up and down arrows to adjust Access Setting Screen 4 by pressing the 4 on the right side of the screen The fourth screen allows you to name the CritiCool MINI device Once set the name or chosen System ID for example MINI 12345 will be sh...

Страница 33: ...ore disconnecting the CureWrap 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 MINI will only monitor temperature when in Standby Mode To initiate Standby Mode press Menu then Standby Water will begin to drain from the wrap and you will see the wrap begin to deflate To resume thermore...

Страница 34: ...de for body thermoregulation CONTROLLED REWARMING Use this mode for slow re warming NORMOTHERMIA Use this mode for fast warming and Normothermia Management If you wish to change the mode press Menu then Mode Select then OK to change the mode There are 3 possible modes TARGETED TEMPERATURE MANAGEMENT TTM The default mode for body thermoregulation CONTROLLED REWARMING Use this mode for slow re warmi...

Страница 35: ...GETED TEMPERATURE MANAGEMENT Use this mode To reach a preset set point To maintain patient temperature For manual rewarming TTM is the default mode and should be using for cooling followed by rewarming to maintain a temperature or for manual rewarming TTM is indicated at the top with a snowflake and the word TTM 35 ...

Страница 36: ... CONTROLLED REWARMING Controlled Rewarming is used when controlled rewarming after cooling is preferred Controlled Rewarming will use the Rewarming Step selected in Settings Screen 1 to gradually rewarm the patient in a stepwise fashion To initiate Controlled Rewarming press Menu then Controlled Rewarming then OK An alarm will appear noting that temperature regulation is paused until the alarm is ...

Страница 37: ...rming is initiated this screen will appear Rewarming with a gauge icon will appear at the top of the screen and Target Temperature will now appear as a normothermic temperature 36 5 Target Temperature can be adjusted by using the Set Point Key Controlled Rewarming will bring the patient to the Target Temperature gradually using the rewarming rate chosen in Settings The default rewarming rate is 0 ...

Страница 38: ...ewarming It has no rewarming steps The CritiCool MINI warms the patient to reach and maintain the selected Set Point Normothermia mode should not be used after a patient was cooled It has no rewarming steps It simply warms the patient to reach and maintain the desired set point The Normothermia mode is indicated at the top with a sun icon and the word Normothermia 38 ...

Страница 39: ...een for certified technicians Reference the Service Manual for further instructions 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 S...

Страница 40: ... hose with inserted drain plug into a sink or water receptacle Touch Start and wait for the message water tank is empty Clean and disinfect the machine and accessories as per the hospital protocol See user manual for complete instructions Drain Plug Here we learn how to drain CritiCool MINI The drain plug shown in the image comes attached to the end of the blue water connecting hoses PN 200 00109 ...

Страница 41: ...essed by a Belmont trained Biomedical Technician The Thermal Disinfection screen can only be accessed by those trained by Belmont or an authorized Belmont distributor to service Belmont equipment It would be performed during an annual periodic maintenance During thermal disinfection the device is heated internally to over 70 degrees C for nearly 3 hours 41 ...

Страница 42: ...d Hydrachem Limited Precise Healthcare Sigma Millipore Aldrich Thermofisher Scientific 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 Here are the routine care instructions for CritiCool MINI After each use the device surfaces should be cleaned...

Страница 43: ...ould be thoroughly rinsed with water Sterilization Probes can be sterilized with Ethylene oxide Do not autoclave 5 Drop sodium dichloroisocyanurate NaDCC tablets or powder into the 1 2 liter 0 317 gallon water tank as per the NaDCC manufacturer s instructions and run the machine for 30 minutes 6 Drain water from water tank refer to the operator s manual for detailed instructions 7 Disconnect the H...

Страница 44: ...n o Alarm sound o Operation screen o Thermoregulation continues o System function status is on The CritiCool MINI uses two types of messages There are two types of alarms Error messages present with an error icon in the top left corner whereas informative messages provide a small text message on the bottom of the screen Error messages require immediate action whereas informative messages are as th...

Страница 45: ... Set Point Staff awareness to patient s core temperature is needed o Alarm sound o Operation screen o Thermoregulation continues o System function status is on ALARM MESSAGE 1 INFORMATIVE MESSAGE This alarms sounds when the core temperature is more than 0 8 and less than 2 0 degrees lower than the set point temperature 45 ...

Страница 46: ...lation ALARM MESSAGE 2 ERROR MESSAGE o Alarm sound o Error Message screen o Troubleshooting guidelines o Error icon is on This error message sounds when either 1 the core temperature is 2 degrees or more below the set point temperature Or 2 the patient s core temperature has dropped below 31 degrees In either case water flow to CureWrap will stop The patient s core probe should be checked and when...

Страница 47: ...ch to confirm Core temp and Start Re warming o Alarm sound o Error Message screen o Troubleshooting guidelines o Error icon is on 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 The directions on the screen should be followed check the position of the core probe in t...

Страница 48: ...ureWrap is folded ALARM MESSAGE 4 CHECK WATER TUBES o Alarm sound o Error Message screen o Troubleshooting guidelines o Error icon is on Solve the problem and the message will disappear 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 Simply check the hoses and or smooth out the hoses or w...

Страница 49: ...bilities may be reduced Battery Level Indicator Battery Level Indicator Battery Charging In Progress Indicator Battery Charging In Progress Indicator The device ships with a battery that should be charged once installed Once charged CritiCool MINI can run on battery for up to 60 minutes but cooling and warming capabilities may be reduced The charge indicator on the screen shown also doubles as the...

Страница 50: ...l MINI 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 When the patient is adjusting to the set point temperature there will be 12 minutes of wate...

Страница 51: ...g into wrap if water temperature 42 C CritiCool MINI turns off thermoelectric coolers TECs if water temperature 43 C no water flow CritiCool MINI shuts off if water temperature reaches 44 C with Halt 3 no water flow The minimum water temperature in the device or wrap is 13 degrees Celsius and the maximum is 40 8 There are multiple safety mechanisms built into the device to avoid high and low water...

Страница 52: ... PRODUCT UPDATES Alarm sound Muting alarms Icon for muted alarm Colors From To Version 2 0 of CritiCool MINI has a new alarm sound press the microphone icons to play the prior alarm sounds and the new buzzer sound The icon for a muted alarm has also changed for version 2 0 see left images 52 ...

Страница 53: ...DICAL TECHNOLOGIES Proprietary Confidential 701 00320 Rev A SOFTWARE V2 0 PRODUCT UPDATES Muted alarm icon Colors All red has been removed from the screens The red triangle for alarms now flashes black and then yellow 53 ...

Страница 54: ...DICAL TECHNOLOGIES Proprietary Confidential 701 00320 Rev A SOFTWARE V2 0 PRODUCT UPDATES Muted alarm icon Colors The Standby screen in version 2 0 similarly now features blue rather than red in the banner at the top 54 ...

Страница 55: ... Enter into Settings section found in CritiCool MINI User Manual Appendix A at the end of the CritiCool MINI User Manual The passcode for the settings screen 6873 should be written into the user manual in two places once a user has been trained 1 The Settings section 2 Appendix A at the end of the manual 55 ...

Страница 56: ...ate 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 Do not use the CureWrap to lift the patient Avoid handling the CureWrap with sharp objects Here are the most important takeaways for today with the most important one being to keep the wrap loose around the patient 56 ...

Страница 57: ...701 00320 Rev A Please email or call tech support with questions 57 ...

Страница 58: ...THANK YOU Thank you for learning about CritiCool MINI 58 ...

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