Belmont CritiCool MINI Page 2 User Manual Download

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DDT-320-000 Rev G Belmont Medical Technologies

Page

114

Conformity according to the Council Directive 93/42/EEC as amended by 2007/47/EC

US Representative:

Belmont Medical Technologies
780 Boston Road
Billerica, MA 01821 USA
Phone +1 978.663.0212
Fax 978.663.0214
www.belmontmedtech.com

European Representative

Emergo Europe BV
Prinsessegracht 20
2514 AP The Hague
The Netherlands

+31 (0) 70 345 8570

Publication No. DDT-320-000

Registered trademarks are the intellectual property of their respective holders.

Summary of Contents for CritiCool MINI

Page 1: ...CritiCool MINI User Manual English DDT 320 000 Rev G...

Page 2: ...gies 780 Boston Road Billerica MA 01821 USA Phone 1 978 663 0212 Fax 978 663 0214 www belmontmedtech com European Representative Emergo Europe BV Prinsessegracht 20 2514 AP The Hague The Netherlands 3...

Page 3: ...erate the system These operators must first have a full understanding of the proper operation of the system The information provided in this manual is not intended to replace regular medical training...

Page 4: ...other goods caused by the following a Installed operated maintained contrary to Belmont Medical Technologies instructions notes or warnings under this manual b Ignoring any of the warnings precautions...

Page 5: ...gs 17 External Features 18 Garment Wrap 20 Reusable Temperature Probes 22 Disposable Temperature Probes 23 System Specifications 24 CHAPTER 3 INSTALLATION 28 Pre installation Requirements 28 CHAPTER 4...

Page 6: ...ement 84 CHAPTER 7 TROUBLESHOOTING 85 General 85 Troubleshooting Guide 85 CHAPTER 8 CLINILOGGER INSTALLATION AND OPERATING INSTRUCTIONS 93 Overview and Installation 93 Using the CliniLogger Viewer App...

Page 7: ...en 54 Figure 26 Graphic Parameters Display 55 Figure 27 Select Service 56 Figure 28 Start Emptying Panel 57 Figure 29 Emptying Water Performing Panel 58 Figure 30 Adjustable Alarm Limits 59 Figure 31...

Page 8: ...Messages 61 Table 6 Technical Messages and Alarms 63 Table 7 Wrap Ordering Information 73 Table 8 CritiCool MINI Accessory Kit with Reusable Probes 74 Table 9 CritiCool MINI Accessory Kit for Disposab...

Page 9: ...lation equipment can be potentially harmful to the patient 3 Do not plug wet probes into the sockets of the CritiCool MINI device 4 The user should verify that no fluids are present at the skin Wrap i...

Page 10: ...urce and correct the problem before proceeding 4 If the device sounds an alarm and or presents a display other than the standard Belmont Medical Technologies display the operator should proceed accord...

Page 11: ...to keep CritiCool MINI at a safe distance from devices emitting radio frequency RF Refer to Appendix B for recommended separation distances between the CritiCool MINI and the RF source Improper Use Im...

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

Page 13: ...bols Table 1 Labels and Symbols Symbol Description CE mark of conformity AC Voltage Fuse The serial number for this product Catalogue number European Authorized Representative Caution refer to user ma...

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

Page 15: ...d the wrap The CritiCool MINI device functions as a control unit and a cooling heating pump which circulates water The control unit monitors the patient s core temperature through specific probes and...

Page 16: ...lation the flow cycle is 12 minutes ON and 1 minute OFF In steady state when the Core Temp is within the Set Point range the cycle is 12 minutes ON and 12 minutes OFF CritiCool MINI Battery CritiCool...

Page 17: ...s Charging should be performed in a fire safe area away from flammable surroundings Charging should be performed in an environment temperature of between4 C and 30 C 39 2 F 86 F Use only the Belmont M...

Page 18: ...View 1 Display Touch Screen 2 Functional Buttons 3 On Off Button 4 Battery Indicator 5 AC Indicator 6 Speaker 7 Core Sensor Socket 8 Surface Sensor Socket 9 Core Out Temperature 10 Water In Quick Coup...

Page 19: ...Rev G Belmont Medical Technologies Page 19 of 114 Rear View Key CritiCool MINI Rear View 1 Air Outlet Grille 2 Rear Side Cover 3 Fan 4 Air Inlet Grille 5 AC Power Plug 6 RS 232 Communication Figure 3...

Page 20: ...ensure maximum body surface coverage The Wrap is intended to fit loosely Review the CureWrap instructions for use leaflet supplied with the wrap for further information The water s exit and entrance p...

Page 21: ...Kg 0 698 0 602 CureWrap Infant Assorted PED SM008 2 5 4 0 Kg x4 4 0 7 0 Kg x4 0 659 0 448 0 698 0 602 Accessories The following accessories are available for use in conjunction with the CritiCool MINI...

Page 22: ...ture probe gray measures core body temperature when inserted into the patient s body The plug of the probe cable is inserted into the gray core socket at the front of the CritiCool MINI device Infant...

Page 23: ...dications for the probes prior to use Disposable Surface Temperature Probe The disposable surface temperature probe is attached to the reusable surface adapter green The adapter is plugged into the gr...

Page 24: ...rge the battery Connecting Tubes for Wraps Two flexible 2 5 m long reusable connecting tubes connect the wrap with the CritiCool MINI device to enable the flow of water between them The tubes are supp...

Page 25: ...spital tra hospital tra hospital transport nsport nsport nsport The CureWrap The CureWrap The CureWrap The CureWrap is a flexible 3D single is a flexible 3D single is a flexible 3D single is a flexibl...

Page 26: ...ntrolled Rewarming Default Target Temp Default Target Temp Default Target Temp Default Target Temp 36 5 C Controlled Rewarming Controlled Rewarming Controlled Rewarming Controlled Rewarming Default Ra...

Page 27: ...are Hardware Connector Connector Connector Connector DB9 connector for serial interfacing to CritiCool MINI or general PC Size Size Size Size 35 x 65 mm Controller Controller Controller Controller MSP...

Page 28: ...n placing the device 384 mm W x 323 mm D x 212 mm H 15 11 W x 12 71 D x 8 5 H Electrical Requirements 100 240V 50 60 Hz WARNING To avoid the risk of electric shock this equipment must only be connecte...

Page 29: ...alone 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 authorized representative or d...

Page 30: ...em for the different modes of operation CritiCool MINI Functions CritiCool MINI is used for patient thermoregulation NOTE The system starts up in one of the two functions according to the Settings see...

Page 31: ...end of the Self Test an alarm is automatically activated CritiCool MINI Screen Controls The CritiCool MINI screen is a touch screen with additional hard keys to the right of the panel Table 4 CritiCo...

Page 32: ...chnologies Page 32 of 114 QCC Quick Coupling Connector The Quick Coupling Connectors are located at the front of the CritiCool MINI device see circle below and are connected to the Wrap by the connect...

Page 33: ...sound is produced 2 Verify that the tubes have been locked by lightly tugging them towards you To disconnect the connecting tubes 1 Press the metal flange and pull out the connecting tubes Temperatur...

Page 34: ...ntal Requirements 2 Remove the water tank feeder cover and pour in only sterile water until the maximum allowable level is reached minimum water temperature 13 C 55 4 F 3 Observe the water level indic...

Page 35: ...f the package and place it on the bed or underneath the patient See Table 2 CureWraps CAUTION Power interrupt The CritiCool MINI has a battery backup that if charged will continue operation for up to...

Page 36: ...gus 3 Insert the surface temperature probe or green adaptor cable reusable or disposable into the right socket labeled SURFACE color coded with green on the front of the device 4 Attach the surface te...

Page 37: ...ds you 4 Connect water tubes to wrap and to CritiCool MINI Open the clamps on the wrap if necessary and the wrap will automatically fill 5 Now that the wrap has filled secure the wrap to the patient R...

Page 38: ...mode highlighted Touch the required mode then touch OK The Thermoregulation Main Screen Control Panel appears Figure 7 Main Screen Once CritiCool MINI is turned on all operating functions are control...

Page 39: ...patient being careful to keep a finger s breadth between the patient and the wrap NOTE Before securing the wrap to the patient with the Velcro strips confirm that the wrap has filled with water Contro...

Page 40: ...s Page 40 of 114 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 MINI Par...

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

Page 42: ...y and maintaining the water temperature for when returning to TTM or Normothermia modes During Standby mode a message displays showing only the patient s temperature NOTE During Standby Mode there is...

Page 43: ...step in temperature for a predefined period The step is always related to the core temperature reached at the end of the previous stage From the settings screen you can choose the rewarming rate Norm...

Page 44: ...he TTM Set Point temperature for the patient may be changed by using the Set Point Control icon The system provides the physician with the option of selecting a body temperature in the range of 30 C 4...

Page 45: ...f temperature change depends on several clinical factors including the size of the patient medications being administered and health indicators Controlled Rewarming Mode This mode is used for Controll...

Page 46: ...rtual Set Point by 0 2 C to 33 5 0 2 33 7 C for a period of 30 minutes Assuming that at the end of the 30 minutes period the core temperature has reached 33 7 C the rewarming algorithm adds 0 2 C to t...

Page 47: ...the rewarming process CritiCool MINI starts to heat the water and starts circulation of water in the wrap NOTE In the Controlled Rewarming mode the set point display changes to Target Temperature wit...

Page 48: ...ion health indicators and theenvironment If during the rewarming phase the core temperature becomes more than 0 8 C below the Target Temperature the following message appears If during the rewarming p...

Page 49: ...d select a target temperature that is slightly above the core temperature see Controlled Rewarming Mode on page 45 and wait until the core temperature reaches the new target temperature Increase the t...

Page 50: ...mia The CritiCool MINI device operates at the optimal level to obtain the desired set point temperature Exceeding the Normothermia Range If the desired set point temperature is set to be out of normot...

Page 51: ...s screen is ___________________ To pre configure the settings 1 From the Menu panel choose Settings 2 Enter the password The settings window is displayed 3 Touch the page numbers to move between the p...

Page 52: ...ettings Screen 2 Settings Screen 2 includes adjustable alarm limits for High patient temperature Low patient temperature High water temperature Settings Screen 3 Settings Screen 3 includes the Time an...

Page 53: ...nt Medical Technologies Page 53 of 114 Settings Screen 4 Settings Screen 4 includes a feature for customizing the System ID of the CritiCool MINI ex MINI 12345 Figure 23 Settings Screen 4 Figure 24 Ma...

Page 54: ...mic temperature NOTE Upon start up the default set point for TTM Mode is 33 5 C 92 3 F Upon start up the default set point for Normothermia Mode is 36 5 C 97 7 F After start up it is possible to chang...

Page 55: ...is displayed Figure 26 Graphic Parameters Display The graphic display includes the following The care time from the start of use and date are displayed at the top of the graph The exact time is displ...

Page 56: ...e 56 of 114 Services The Services option is in the Menu panel Services include the following Empty System Check Technician Thermal Disinfection The System Check technician and thermal disinfection are...

Page 57: ...ank 1 Switch to Standby Mode 2 Disconnect the wrap from the system Dispose of the wrap 3 Connect a male draining connector to the water out of the CritiCool MINI anddirect the tube to a sink or 2 lite...

Page 58: ...during disconnection To replace the Wrap 1 Switch to STANDBY and wait a minute to let the water return to the system 2 Close wrap clamps to avoid water spill 3 Disconnect the connecting tubes from th...

Page 59: ...chnical messages represent lower priority alarms NOTE Sound pressure of the alarms is 67 5 dBA at a distance of 10 centimeters Constant alarms occur in the following states Halt condition Select mode...

Page 60: ...ages thermoregulation stops Safety messages alert the clinician that the system has either overcooled or overheated the circulating water The safety messages include WATER TEMPERATURE TOO LOW WATER TE...

Page 61: ...r confirmation of the setting by touching the OK key Clinical messages include the following Table 5 Clinical Messages Message Screen Message Description Core Readout Too Low This message appears when...

Page 62: ...minutes Low Core Temperature This message appears when core temperature is 0 8 C less than the set point or according to alarm settings Patient s Temperature is below XX X C An alarm sounds but thermo...

Page 63: ...ight appear Follow the instructions of the technical messages to solve the problem For example add water if necessary or connect temperature probes if they are not connected Table 6 Technical Messages...

Page 64: ...DDT 320 000 Rev G Belmont Medical Technologies Page 64 of 114 Message Screen Message Check water tubes Low battery connect to power supply Add water...

Page 65: ...DDT 320 000 Rev G Belmont Medical Technologies Page 65 of 114 Message Screen Message Tank is empty...

Page 66: ...rmation only and do not require any user response The message appears at the bottom of the main screen The informative messages include Message Screen Message Description Body temperature in accepted...

Page 67: ...s Page 67 of 114 Message Screen Message Description Out of Normothermia Range Appears when a set point temperature is chosen 32 C or 38 0 C outside of Normothermia Range Touching OK confirms the new s...

Page 68: ...re alarm In this condition temperature control continues and warms the patient toward the set point An informative message appears and an audible alarm will sound Pressing MUTE stops the audible alarm...

Page 69: ...not touch OK for over 30 minutes the alarm cannot be silenced While the message appears thermoregulation is paused and the machine switches into standby mode water stops flowing to the wrap Check tha...

Page 70: ...e indicates that water is now flowing into the wrap and that thermoregulation is continuing Once OK has been touched the Temperature Regulation Paused message will reappear every 30 minutes that its a...

Page 71: ...is case a message appears with an alarm but thermoregulation continues Patient Core Temperature Target Temperature and Virtual SP Core Temp 2 C This means that the core temperature probe is probably o...

Page 72: ...the core temperature probe is in place and the low temperature represents the true patient status then touch OK to re activate temperature control NOTE If the user disregards the message and does not...

Page 73: ...ber as listed in this chapter as well as the serial number of your CritiCool MINI device Available Wraps Models for various wraps are available See below Table 7 Wrap Ordering Information Part number...

Page 74: ...t No Description Number Supplied 014 00005 Reusable Core Temperature Probe Infant Gray 1 014 00021 Reusable Surface Temperature Probe Green 1 200 00109 Connecting Water Tubes 2 by 2 Way 1 200 R0130 Fi...

Page 75: ...002 00069 Male Connector for Draining Water Tank 25 pack 200 R0130 Filter Unit internal 017 00250 CliniLogger assembly 200 00109 Connecting Water Tubes 2 by 2 Way 014 00005 Reusable Core Temperature...

Page 76: ...nt Medical Technologies or authorized agents of Belmont Medical Technologies Service Information When communicating with authorized Belmont Medical Technologies representatives regarding the CritiCool...

Page 77: ...use Before Storage Add Sodium Dichloroisocyanurate NaDCC to the water tank and run for 30 minutes in Standby Mode Drain water using Empty under Services menu Clinician or Hospital Staff As required by...

Page 78: ...roisocyanurate NaDCC powder or tablets Sterile water 0 22 micron filtered tap water approximately 1 2 liters Recommended Disinfectants for External Surfaces Chlorinated bleach solution 5 25 sodium hyp...

Page 79: ...e NaDCC powder or tablets as recommended by NaDCC manufacturer into 1 2 liter water tank 7 Run the device in Standby Mode for 30 minutes 8 Empty the device see Figure 27 Select Service 9 Turn off the...

Page 80: ...ouch Thermal Disinfection and then OK 3 The process is password protected Enter password 4 Touch OK The following verification message appears 5 Verify that the tank is full Connect the bypass tube an...

Page 81: ...micron filtered tap water Always drain the water after the thermal disinfection process Cleaning Disinfecting and Sterilization of the Reusable Temperature Probes The cleaning disinfection and sterili...

Page 82: ...ction Pressure meter Heating and cooling unit Temperature of water inflow and water outflow Successful completion of the System Check service indicates that the CritiCool MINI device is operational NO...

Page 83: ...g you to confirm start of System Check 3 Touch Start System Check is initiated The progress bar that appears on the screen indicates the progress System Check takes about 10 minutes When the process i...

Page 84: ...ge particles and 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...

Page 85: ...d a malfunction occur consult the Troubleshooting Guide Troubleshooting Guide Figure 42 CritiCool MINI System Malfunction No Message Troubleshooting Guide lists some possible scenarios that may indica...

Page 86: ...dentally punctured during the course of the operation Turn off the CritiCool MINI and allow the water to return to the reservoir Replace the Wrap if possible Water leaks from the connector between Wra...

Page 87: ...nd of the CureWrap connecting tubes to the right quick coupling connector or Connect the gray colored end of the CureWrap connecting tube to the right quick coupling connector 2 Connect the special ma...

Page 88: ...r tank float is jammed Open water tank cap Refill water tank to the maximum Insert a long object to release the float Add Water Water level is too low Refill water tank to the maximum The alarm can be...

Page 89: ...creases folds or objects that obstruct the water flow in the wrap Check clamps Pressing Alarm Mute silences the buzzer for 30 minutes Check Core Temperature Probe Misplacement of core temperature pro...

Page 90: ...arm cannot be silenced until the OK button is touched When OK is touched the screen returns to the Main Screen and a message appears for 5 seconds indicating that thermoregulation has resumed Switchin...

Page 91: ...emperature can be configured in settings The alarm and message are issued according to the selected alarm limit The available values are 36 C 36 5 C 37 C 37 5 C 38 C 38 5 C Check that the core tempera...

Page 92: ...obe is in place and follow the patient s temperature Inform the physician Thermoregulation continues The alarm can be muted for 30 minutes Body temperature in accepted range Core temperature reaches a...

Page 93: ...o the CritiCool before the start of the medical procedure Belmont Medical Technologies recommends recording CritiCool device data for one patient at a time At the end of the procedure disconnect the C...

Page 94: ...of 114 CliniLogger Initialization When initialization finishes the following screen appears CliniLogger Installation 5 You can change the installation location by clicking Browse and selecting a new l...

Page 95: ...lect I accept the above License Agreement s to accept the license agreements and click Next The Start Installation window appears Start Installation 7 Click Next you can follow the installation progre...

Page 96: ...s finished the Installation Complete window appears Installation Complete 8 Click Finish to complete and exit the software installation 9 Copy User Ver XX folder from CD to your desktop 10 You can now...

Page 97: ...CliniLogger 2 Click on the CliniLogger icon the CliniLogger window appears CliniLogger Application Window 3 Connect the CliniLogger device to the serial COM1 port of the PC NOTE Verify that the CliniL...

Page 98: ...ogger after saving the data to prepare the device for the next use NOTE You should erase the data on the CliniLogger manually after each patient otherwise the CliniLogger continues to burn data from t...

Page 99: ...DDT 320 000 Rev G Belmont Medical Technologies Page 99 of 114 2 Click Load stored data and choose the file you would like to view...

Page 100: ...ies Page 100 of 114 Choose CliniLogger File Window When the data has been loaded the Complete message appears Complete Message 3 Click View data the graph opens 4 To convert to Excel click Convert to...

Page 101: ...Viewing Panel The CliniLogger viewing panel includes the following data Start date and time received from the thermoregulation device CritiCool MINI Software version of the thermoregulation device Cl...

Page 102: ...Display Area The Graphic Display area consists of three parts Temperature graphs Set point Core and Surface as a function of time Modes and Error area Thermoregulation modes rewarming step and errors...

Page 103: ...h as zooming in and out moving between time zones and detailing the viewed data Temperature Graph Control Buttons These buttons define the shape of the curves in the temperature graphs area the water...

Page 104: ...d cursor to the temperature graph area and grab the curve by pressing the mouse left button and moving the mouse Moving the mouse horizontally will move the graphs horizontally in time and moving the...

Page 105: ...l cursor to the required point of time click to insert the low limit line keep the left key pressed and pull horizontally to the end of the time period desired Once you release the mouse button the im...

Page 106: ...1 Click the Cursor icon 2 Bring the to the cursor location the will convert to a double line 3 Use the mouse to move the double line to a new cursor location NOTE The values of the temperature at the...

Page 107: ...p Rewarm Adult F PowerUp Rewarm Neonate G PowerUp Standby H PowerUp Sel Mode Adult I PowerUp Sel Mode Neonate J Cooling Adult K Cooling Neonate L Warming Adult M Warming Neonate N Rewarming Adult O Re...

Page 108: ...the line is green When CritiCool MINI is circulating the water internally i e in Standby mode the line is white Converting to Excel To convert to Excel 1 On the CliniLogger menu panel select Convert...

Page 109: ...Session Technician Software NOTE The Technician Software can only be run after performing a full installation of the User Software See Installing the Software section for more information on this proc...

Page 110: ...R SERVICE WARNING The following details are necessary to contact your Belmont Medical Technologies representative Keep this form with the User Manual for scheduling annual periodic maintenance and or...

Page 111: ...CliniLogger are given in Table 12 Table 12 Separation Distances in Meters Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz 80...

Page 112: ...ev G Belmont Medical Technologies Page 112 of 114 APPENDIX C DECLARATIONS OF COMPLIANCE Guidance and Manufacturer s declarations of compliance Table 13 Electromagnetic Emissions for all ME Equipment a...

Page 113: ...3 2 Class A The ME EQUIPMENT or ME SYSTEM is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low volta...

Page 114: ...ts batteries and accumulators must be taken to separate collection at the end of their working life This requirement applies to the European Union and other locations where separate collection systems...

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