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Proprietary & Confidential

Internal Use Only

701-00235 Rev. B

STANDBY MODE

To turn on Standby mode:

1. Touch

icon/button

2. Select

Standby

○

Water flow to the CureWrap will stop

○

CureWrap will deflate

○

CritiCool will continue to monitor patient’s temperature

(as long as core temperature probe in place)

To resume thermoregulation:

1. Touch

icon/button

2. Select

OPERATE

•

Turn on Standby mode to stop the water flow to the wrap:

–

End of therapy, before disconnecting the CureWrap

Содержание Criticool 6.3

Страница 1: ...701 00235 Rev B CRITICOOL 6 3 OPERATIONAL TRAINING UPDATED MAY 2020 701 00235 Rev B...

Страница 2: ...701 00235 Rev B INTRODUCTION...

Страница 3: ...MEDICAL TECHNOLOGIES Proprietary Confidential 3 701 00235 Rev B Indication for Use CritiCool is a thermal regulating system indicated for monitoring and controlling patient temperature CRITICOOL INDIC...

Страница 4: ...4 2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B CRITICOOL PRODUCT FAMILY CritiCool Control Unit CureWrap Garments...

Страница 5: ...2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 5 701 00235 Rev B SIMPLE PRECISE EFFECTIVE...

Страница 6: ...IMPLE PRECISE EFFECTIVE Every 133 milliseconds The control unit reads the patient s core temperature through specific probes every 133 milliseconds and adjusts temperature as necessary in order to mai...

Страница 7: ...ntrol as set by the physician Full color touch screen display Simple easy to use interface with intuitive controls Real time monitoring and graphical display of temperature measurements Quick and easy...

Страница 8: ...2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 8 701 00235 Rev B SIMPLE EASY TO USE INTERFACE...

Страница 9: ...Proprietary Confidential 9 701 00235 Rev B CRITICOOL CONTROL UNIT FRONT VIEW Water level indicator Water in coupling connector Water out coupling connector Surface sensor socket Core sensor socket Co...

Страница 10: ...2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 10 701 00235 Rev B CliniLogger CRITICOOL CONTROL UNIT REAR VIEW...

Страница 11: ...o 8 8 lb 0 659 0 448 508 03521 8 4 7 kg 8 8 15 5 lb 0 698 0 602 Pediatric Assortments Pediatric Small 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...

Страница 12: ...701 00235 Rev B SETTING UP CRITICOOL...

Страница 13: ...2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 13 701 00235 Rev B UNPACKING CRITICOOL Keep the original box...

Страница 14: ...2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 14 701 00235 Rev B UNPACKING CRITICOOL...

Страница 15: ...P TTM SETTING UP CRITICOOL 1 Push Down to Lock Wheels 2 Remove this cap to fill 3 Power switch in the back 1 Place the CritiCool unit near the bed and lock the front wheels 2 Fill tank with sterile wa...

Страница 16: ...rnal Use Only 701 00235 Rev B STEP BY STEP TTM SETTING UP CRITICOOL 1 After self test is complete the start up Mode Select screen appears 2 Push OK to select TTM mode default Mode 3 CritiCool is now c...

Страница 17: ...T MEDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B STEP BY STEP SETTING UP CUREWRAP 1 Place the appropriate CureWrap on the bed or underneath patient See CureWrap Instru...

Страница 18: ...l Internal Use Only 701 00267 Rev A CHOICE OF TEMPERATURE PROBE TYPE Reusable Temperature Probes only select markets Disposable Temperature Probes United States all markets Core Infant Adult Disposabl...

Страница 19: ...01 00235 Rev B STEP BY STEP SETTING UP CRITICOOL For use with Disposable Probes Connect Core cable to the Core socket and Surface cable to the Surface socket SURFACE CORE SURFACE on left Green color c...

Страница 20: ...ECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B STEP BY STEP SETTING UP THE PATIENT Patient Connect Core sensor to the Core Adapter Cable and the Surface sensor to the Surface A...

Страница 21: ...B STEP BY STEP SETTING UP THE PATIENT Insert Core sensors into the patient and position the Surface sensor on the patient skin Core Probe Placement Rectal esophageal 014 00322 or 014 00220 Surface Pro...

Страница 22: ...nal Use Only 701 00235 Rev B STEP BY STEP SETTING UP THE PATIENT CritiCool cannot thermoregulate without a valid Core readout Therefore water will not flow into CureWrap until the core probe is connec...

Страница 23: ...IES Proprietary Confidential Internal Use Only 701 00235 Rev B STEP BY STEP SETTING UP CUREWRAP Connect metal fittings on blue hose to metal fittings on the front of CritiCool Water in coupling connec...

Страница 24: ...S Proprietary Confidential Internal Use Only 701 00235 Rev B STEP BY STEP SETTING UP CUREWRAP Connect plastic ends of blue connecting water hoses to wrap Wrap should be filled with water prior to wrap...

Страница 25: ...03521 8 4 7 kg 8 8 15 5 lb 0 698 0 602 Pediatric Assortments Pediatric Small 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 Pediatric Medium PED MD00...

Страница 26: ...00147 are needed for 500 03500 500 03500 is sold in two different boxes of CureWraps 508 03500 includes eight 500 03500 CureWraps PED XL008 includes four 500 03500 and four 500 03548 CureWraps 500 03...

Страница 27: ...THER THAN 500 03500 The 2x2 way Connecting Water Hoses 200 00109 are needed for all wraps other than 500 03500 All wraps except 500 03500 have 2 connectors to the CureWrap The 2x2 Way hoses are includ...

Страница 28: ...P BY STEP TTM The default Set Point SP Temperature is 33 0 C in Adult Mode The Default Set Point temperature for Adult Mode can be adjusted in Settings The default Set Point SP Temperature is 33 5 C i...

Страница 29: ...the patient see CureWrap Instructions For Use Note Ensure clamps to the wrap are open Ensure CureWrap fits loosely there should be a finger s width space Do not use the CureWrap to lift the patient Av...

Страница 30: ...30 2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B Model 500 03500 CureWrap shown SECURING THE CUREWRAP AROUND THE PATIENT...

Страница 31: ...GIES Proprietary Confidential 31 701 00235 Rev B MAIN OPERATION SCREEN Core Temperature Surface Temperature System Function Status Timer Selected Mode Menu Key Temperature Graph Key Set Point Key Set...

Страница 32: ...Confidential 32 701 00235 Rev B CRITICOOL TOUCHSCREEN 5 7 large operational touch screen 5 soft keys Power soft key Soft Button Keys Main Menu Escape Show graph Up Arrow Alarm tone ON OFF Open Settin...

Страница 33: ...LOGIES Proprietary Confidential 33 701 00235 Rev B MENU OPTIONS Touch the Menu Icon Soft Button Key Drop Menu will appear with the following options Once the Menu drop down ESC icon appears touch it t...

Страница 34: ...emperature 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 Touch the Set...

Страница 35: ...PH Use the Temp Graph icon soft key to enter a Graphic Display of the current or last case temperature data CritiCool displays the current case temperature data 1 hour 6 hours 12 hours and 24 hours di...

Страница 36: ...36 2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B SETTINGS SCREEN PASSWORD PROTECTED Password for the Settings Screen ____ Enter once trained See slide 38...

Страница 37: ...eneral Settings Screen 2 Setting Alarm Limits SETTINGS SCREEN PASSWORD PROTECTED There are Four Screens in the Settings mode Push OK to confirm and return to main screen The CritiCool keeps the last s...

Страница 38: ...2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 38 701 00235 Rev B Screen 3 Touch Screen ON OFF Screen 4 Set Date and Time SETTINGS SCREEN PASSWORD PROTECTED...

Страница 39: ...EDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B PASSCODE FOR SETTINGS SCREEN Enter into Settings section 4 18 in CritiCool User Manual Appendix A at the end of the Criti...

Страница 40: ...ton 2 Select Standby Water flow to the CureWrap will stop CureWrap will deflate CritiCool will continue to monitor patient s temperature as long as core temperature probe in place To resume thermoregu...

Страница 41: ...RGETED TEMPERATURE MANAGEMENT TTM The default mode for body thermoregulation CONTROLLED REWARMING Use this mode for slow re warming NORMOTHERMIA Use this mode for fast warming and Normothermia Managem...

Страница 42: ...MEDICAL TECHNOLOGIES Proprietary Confidential 42 701 00235 Rev B TTM The default mode TARGETED TEMPERATURE MANAGEMENT Use this mode To reach a preset set point To maintain patient temperature For manu...

Страница 43: ...cording to the hospital protocol in the Settings screen 1 Select Controlled Rewarming and push OK to confirm Temperature Regulation Paused Switching to AutoRewarm Mode messages appear While these mess...

Страница 44: ...raising patient temperature according to the rewarming step per hour chosen in Settings Rewarming step per hour can be preset in the SETTING screen Rewarming step default 0 2 C hour Rewarming step ran...

Страница 45: ...Rev B NORMOTHERMIA MODE Select Normothermia for fast rewarming Note This mode is used for fast rewarming It has no rewarming steps Algorithm aims to bring patient to the target temperature as quickly...

Страница 46: ...701 00235 Rev B MESSAGES AND TROUBLESHOOTING...

Страница 47: ...Error Message Informative Message MESSAGES TROUBLESHOOTING o Alarm sound o Error Message screen o Troubleshooting guidelines o Error icon is on o Alarm sound o Operation screen o Thermoregulation con...

Страница 48: ...Rev B Core temperature is 0 8 C to 2 C lower than Set Point Staff awareness to patient s core temperature is needed No other action is needed o Alarm sound o Operation screen o Thermoregulation conti...

Страница 49: ...tops Check Core temp sensor position and fix if necessary Touch to confirm Core temp and resume thermoregulation ALARM MESSAGE 2 ERROR MESSAGE o Alarm sound o Error Message screen o Troubleshooting gu...

Страница 50: ...USED When Switching to Controlled Re warming Mode Patient s Core temperature probe position should be confirmed to initiate the automatic process Check Core temp sensor position and fix if necessary T...

Страница 51: ...Check the blue hoses are not kinked bent Check that the blue hoses are flat near the CureWrap connections Check if the CureWrap is folded ALARM MESSAGE 4 CHECK WATER TUBES o Alarm sound o Error Messa...

Страница 52: ...n when patient has yet to reach the target temperature 12 minutes of water flowing 1 minute of no water flow Steady State begins when patient reaches the set point temperature 12 minutes of water flow...

Страница 53: ...5 0 C 36 0 C n a 2 0 C between Set Point and Core Temperature stops water flow to the wrap Only if patient core temp 31 0 C Yes always Patient temp drops below 31 0 C No water flow to the wrap No wate...

Страница 54: ...LOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B NEONATAL PATIENT MODE Default Set Point 33 5 C Set point temperature range 30 40 C To change the set point Press the thermometer key C...

Страница 55: ...et Point 33 0 C To change the set point Press the thermometer key Choose the desired temperature Select OK Selection will not be default To change the default set point Press the MENU button Press Set...

Страница 56: ...ge 13 C 40 8 C Alarms when water temperature is 42 C or 10 C Default high water temp alarm is 42 C Keep it there Automatically stops flowing into wrap if water temperature 42 C CritiCool turns off the...

Страница 57: ...58 2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B SOFTWARE V 6 3 PRODUCT UPDATES Alarm sound Muting alarms Icon for muted alarm Colors Power loss...

Страница 58: ...59 2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B SOFTWARE V 6 3 PRODUCT UPDATES Muted alarm icon Colors Power loss...

Страница 59: ...60 2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B SOFTWARE V 6 3 PRODUCT UPDATES Muted alarm icon Colors Power loss...

Страница 60: ...61 2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B POWER INTERRUPTS CritiCool Versions 6 2 and earlier CritiCool Version 6 3 After July 2020...

Страница 61: ...ICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B TEMPERATURE SPLITTER Patient CritiCool External Device Power Supply Optional accessory Shares patient core temperature with...

Страница 62: ...701 00235 Rev B MAINTENANCE...

Страница 63: ...SCREEN Empty Use this mode to drain the water System Check An automatic system check takes about 10 minutes Technician A password protected screen for certified technicians Thermal Disinfection A pas...

Страница 64: ...y and touch OK to confirm Connect water hoses and make sure the draining plug is connected Place water out hose with inserted drain plug into a sink or water receptacle Touch Start and wait for the me...

Страница 65: ...ONT MEDICAL TECHNOLOGIES Proprietary Confidential Internal Use Only 701 00235 Rev B THERMAL DISINFECTION Thermal Disinfection is Password Protected Can only be accessed by a Belmont trained Biomedical...

Страница 66: ...etween cases drop sodium dichloroisocyanurate NaDCC tablets into the 6 0 liter 1 6 gallon water tank as per the NaDCC manufacturer s instructions and run the machine for 30 minutes NaDCC is sold by ma...

Страница 67: ...should 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 6 0 liter 1 6 gal...

Страница 68: ...2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 69 701 00235 Rev B PACKING CRITICOOL FOR SHIPMENT...

Страница 69: ...2020 BELMONT MEDICAL TECHNOLOGIES Proprietary Confidential 70 701 00235 Rev B PACKING CRITICOOL FOR SHIPMENT...

Страница 70: ...ter 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 s...

Страница 71: ...701 00235 Rev B TECHNICAL SUPPORT USA 855 397 4547 WORLDWIDE 1 978 663 0212 TECHSUPPORT BELMONTMEDTECH COM WWW BELMONTMEDTECH COM...

Страница 72: ...701 00235 Rev B THANK YOU...

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