User Manual
Contents
1. 2 4 ACCESSORIES ac ae O du i a aaa M MR MMOL aci alte la 2 7 Chapter 3 Installation FE 3 1 Pre installation 3 1 Space and Environmental 3 1 Electrical Requirements occ couloir s Yw WA d ipte c4 S 3 1 Unpacking and 3 1 Assembling the Handle dg CAD HEN EF 3 1 Equipment List iie 215209 e e NL wie beta 3 2 Moving the cede 3 3 Preparations costa ctio c eM cL roe pM erm cuu E 3 3 Locking and Unlocking the Trolley Wheels 3 3 Storage Conditions and 3 3 Nu s _ 3 3 MTRE amp ii CritiCool Pro Operating Manual Chapter 4 Operating InstFlclioHs ecas Ee aa ARNAW aia AN 4 1 dL WE GUDD YU it 4 1 Controls Indicators and Connections 4 Main Power osu aa Da 2 eee haw ERE 4 QCC Quick Coupling Connector 4 1 Sensor Sockets mart sacii2. System Description CritiCool Pro Operating Manual XXX XXXcm ux Figure 2 4 Measurments Table 2 1 CureWrap 2 6 Table of CureWrap Sizes Part No Height Width Garment Patient Patient Merer meter Area sg m Height weight In Inches Part No 3500 2 030 1 354 2 324 All adults sizes Part No 3548 1 582 1 193 1 399 48 53 Part No 3541 1 390 1 054 1 089 41 48 Part No 3536 1 225 0 841 0 763 36 41 Part No 3531 1 118 0 740 0 637 31 36 Part No 3525 0 981 0 628 0 425 25 31 7 11 kg Part No 3521 0 698 0 602 0 347 21 25 4 7 kg Part No 3518 0 659 0 448 0 219 18 21 lt 4 Kg For use only out of USA MTRE amp CritiCool Pro Operating Manual Accessories MTRE amp The following accessories are needed in order to operate the CritiCool Pro system the Human Temperature Sensors a Reusable Sensors There are three color coded sensors Core gray Surface green and Infant Core gray Both core and surface sensors must be plugged into the CritiCool Pro device The core sensor must be inserted and the surface sensor must be attached to the patient for the device to function properly b Disposable Sensors Disposable sensors are attached to two color coded adapters gray Core and green Surface The core sensor must be inserted and the surface sensor must be attached to the patient for the device to function properly Se
3. c bet ti i isa d 4 2 Preparing System for 4 2 SUTIN ee gat aate S fees Glue eu a ble a ata 4 2 System GLUD DG np 4 2 Turning on System GTA new I GY i e YE Rad 4 4 Mua i ipea koe D adiu eto 4 5 Cooling Therapy Control 1 4 5 Selecting Modes D Cb EN e Cd as 4 6 Set Pott RF esL et able azotat E 4 7 Target Temperature 4 9 RE d n DN Y dea e etd 4 10 Getting 4 11 Inserting and Attaching Human Sensors 4 1 Attaching Surface SellsOE ack doe Ge oe E MR ERI dA ees NIA 4 11 Fastening Garment to 4 12 Replacing he Garmentose oro E adi 4 12 Cooling Mode was iis eee AG a ARA AYN GY GAWR 4 12 Wanne Mode en dco steep sted wae USA Rum trate wie de rd 4 13 Normothermia Management ssa es eww be be dea nae bes 4 14 arming NIGd amp iy see e ata e te Os RRER ER E bx ud ose d 4 14 STANDBY Modessa DUCK ISP GR ey Y
4. with adhesives to the patient s skin 2 7 System Description 2 8 CritiCool Pro Operating Manual Disposable Surface Sensor Adapter Part No 014 00029 The disposable sensor is attached to the surface sensor adapter green The PL plug of the adapter is plugged into the green surface sensor socket at the front of the CritiCool Pro device The sensor is attached with adhesives to the patient s skin and measures surface body temperature Table 2 2 Sensor and Data Provider Input Specifications PartNo Name Description Accuracy Resolution Type 014 00020 Core Inner body 0 3 C 0 1 C Medical Grade temp Thermistor 014 00021 Surface Skin temp 0 3 C 0 1 C Medical Grade Thermistor 014 00005 Core Infant Inner 0 3 C 0 1 C Medical Grade Infant body temp Thermistor Detachable Electric Power Cable amp Plug See Table 5 2 Accessories Inventory on page 5 2 Connecting Tubes for CureWrap Part No 200 00147 Two flexible 2 5 m long color coded connecting tubes connect the CureWrap with the CritiCool Pro device to enable the flow of water between them The tubes are supplied as a paired unit with two male Quick Coupling Connectors at the CritiCool Pro device end and with three female Quick Coupling Connectors at the CureWrap end Connecting Tubes Part No 200 00109 Two flexible 2 5m long connecting tubes connect the ThermoWrap with the CritiCool Pro device
5. 00005 Infant Core sensor Gray 014 00017 Power cord European Standard 014 00016 Power Cord USA Standard Hospital Grade 641 345 090 Interface cable CritiCool to VitaLogik 024 00010 CritiCool Pro User manual English MTRE amp CritiCool Pro Operating Manual CHAPTER 6 MAINTENANCE Introduction This chapter outlines the maintenance instructions for the CritiCool Pro system Qualified hospital staff may perform routine maintenance unless otherwise specified WARNING repair and servicing of CritiCool Pro system should be performed only by MTRE Advanced Technologies LTD or autho rized agents of MTRE Advanced Technologies LTD Service Information When communicating with authorized MTRE representatives regarding the CritiCool Pro system always state the model and serial numbers on the identification label located on the rear panel of the CritiCool Pro device see Figure 1 1 When communicating regarding Garments refer to the label on the Garment package for lot number details Routine Maintenance The CritiCool Pro device should be periodically inspected and maintained to make sure that it remains in optimum condition A recommended routine inspection and maintenance schedule is provided in Table 6 1 System Calibration is performed monthly by the hospital Biomed engineer Refer to CritiCool Pro Service manual section XXX for calibration procedure Sterilization of Reusable Sensors and
6. 5 C 92 3 F for neonates and 33 0 C 91 4 F for adult You can change the set point temperature for cooling See Set Point Setting on page 4 7 When there is a difference between the set point temperature and the coretemperature a further decrease in the set point temperature will not affect the water temperature in the Garment For example if the Core temperature is 34 C 93 2 F and the set point temperature is 33 C 91 4 F decreasing the set point temperature will not accelerate the cooling of the water in the CritiCool Pro system The CritiCool Pro device automatically operates at the optimal level to obtain the desired set point temperature MTRE CritiCool Pro Operating Manual WARNING default setting is intended to maintain mild hypothermia WARNING desired set point temperature should only be set by the physi cian or under the order of a physician Note The system provides the physician with the option of selecting a body temperature in the range of 30 C to 40 C 86 F 104 F After setting the set point temperature follow the on screen instructions and operate as instructed Example Figure 4 9 shows a screen with the Core too Low Check Core amp Operate 18 message Neonatal Cooling Core Temperature Set Point 22 7 Surface Temp Operate Figure 4 9 Alarm Message Core too low The sensor reads the room temperature until it is inserted into the patient T
7. 6 2 MTRE amp CritiCool Pro Operating Manual gt the filter assembly CAUTION The filter is marked with an arrow indicating the direction of water flow see Figure 6 1 You must assemble the filter in the manner indicated Figure 6 1 Filter Orientation Connect the tubes to the new filter assembly Insert both tubes with suitable force to ensure that they are secure Position the filter clamp in the chassis and tighten the filter clamp screw by hand see Figure 6 2 LI Filter Clamp all V ERE came X M Screw V db Figure 6 2 Filter Assembly 3 Close the rear cover and tighten the thumb captive screws by hand MTREG 6 3 Maintenance 6 4 CritiCool Pro Operating Manual Table 6 1 Inspection and Maintenance Schedule Frequency Inspection Service Performed Before each treatment e Clean connecting tubes and Quick Coupling Connector with a wet cloth e Perform visual inspection for any mechanical failure in sensors connecting tubes and power cable e Perform a visual inspection of the exterior of the CritiCool Pro Device Staff As reguired by hospital clinic protocol Routine external cleaning and disinfecting Staff Monthly System Calibration Check BMD Semi annually Annually Thermal verification BMD Replace filter BMD Perform Thermal Verification accordi
8. Detailed operating instructions for the CritiCool Pro system for the different mode of operation Controls Indicators and Connections Included in this section is a short description of the following e power switch e OCC Ouick Coupling Connectors e 500501 sockets The following functions of the CritiCool Pro device are described e Cooling e Warming e Re Warming e Standby Empty Main Power Switch The main power switch located on the rear side of the unit switches the CritiCool Pro device ON and OFF QCC Quick Coupling Connector The Quick Coupling Connectors are located at the front of the CritiCool Pro device and are connected to the Garment by means of the connecting tubes MTREG 4 1 Operating Instructions CritiCool Pro Operating Manual gt Toconnect the Connecting Tubes 1 Lock the connecting tubes by pressing them against the connectors When locked a clicking sound is produced 2 Verify that the tubes have been locked by lightly tugging them towards you gt disconnect the Connecting Tubes 1 Press the metal flange and pull out the connecting tubes Sensor Sockets There are two sensor sockets located in the front of the CritiCool Pro device gt Toconnect the Sensors 1 Insert the appropriate reusable sensor or disposable sensor adapter into the designated socket gt To disconnect the Sensors 1 Pull the appropriate reusable sensor or disposable adapter out of its socke
9. Menu key to open the Re Warm Setup panel SARA BED 1 RR Re Warm Setup pe Figure 4 8 Re Warm Setup Panel 4 10 MTRE amp CritiCool Pro Operating Manual 2 Rotate the Quickey to change the Temperature Step then click to select 3 Rotate the Ouickey to change the Time Step in minutes then click to select 4 Click Main Screen to accept Getting Started gt To get started 1 Place the appropriate Garment on the bed or underneath the patient see the Instructions for Use leaflet 2 Connect the connecting tubes to the CritiCool Pro device and to the Garment Note Select the corresponding connecting tubes according to the Garment in use 3 Insert the reusable core and surface sensors or the disposable core and surface adapters into the CritiCool Pro device sockets as described in section Accessories on page 2 7 Note The CritiCool Pro device does not initiate thermoregulation if the core sensor is not properly inserted into the patient Ensure that direct patient feedback is monitored at all times Inserting and Attaching Human Sensors CAUTION For proper use of the CritiCool Pro device the core sensor must be inserted and the surface sensor must be attached Insert the Core Sensor into the Patient Insert the reusable core sensor or the disposable core sensor or connect the disposable core sensor to its adapter as soon as possible into the patient prior to fastening the Garment Attachi
10. ay d aa y 8 1 ONE LS gei n HE HN 8 1 Auxiliary Systems 8 1 ACEA E y erat arse aci 8 2 Operations eA e YN ated NIAI GN be a AGO ni aa 8 2 Storage and Transport without 8 2 BICCIICILY Da Y 8 2 Safety eR EA XN ENG Y XS i ta SN 8 2 a oua DE DWN eu EEO 8 3 Chapter 9 Customer Service Representative 1 MTRE amp CritiCool Pro Operating Manual MTRE amp CritiCool Pro Operating Manual LIST OF FIGURES Figure 1 1 Label Placement for the CritiCool Pro Device RN 1 4 Figure gt l Front View gata ti lite a tt ti d nl aa FYSA nat n d 2 2 Ligure 2 2 Side View yu lata ata dat ari ce a aa da da s ale a da 2 3 2 3 Rear qe 2 4 Figure 22 Meas urments ce Ge ea aa a da da d d ada ata aa adela 2 6 Figure 3 1 Handle Assembly 3 2 Figure 4 1 CritiCool Setup in VitaLOogik ee ia aaa a alt nas 4 3 Figure 4 2 Full Screen monitor display eese eee eee eee eene entente net
11. device cool Do not use de ionized or distilled water Use tap water only When X ray imaging is performed on a patient wearing a Garment shadows from the Garment may appear on the X ray film Avoid inserting any sharp object between the patient and the Garment Improper Use MTRE amp Improper use of the CritiCool Pro system can lead to skin lesions electrical hazards and severe changes in body temperature WARNING The technical principles clinical applications and risks associ ated with circulatory support must be thoroughly understood before using this product Read the entire manual before attempting to activate the system Completion of the training program prior to using the CritiCool Pro system is mandatory CAUTION U S Federal law restricts this device to sale by or on the order of a physician 1 3 Safety Precautions CritiCool Pro Operating Manual Labels CritiCool Pro Device Labels CritiCool Pro MITRE Advanced Technologizs Ltd 4 He Yarden st Yavne 81228 P O Box 102 Rehovot Israel www mtre com P N 200 02136 Serial 9936138800014 lt gt 230V 120V 50 60Hz 500W 4 2x6 3A 250V x Mfg 2010 wi CEAR Complies With 21CFR 870 5900 SURFACE Figure 1 1 Label Placement for the CritiCool Pro Device 1 4 MTRE amp CritiCool Pro Operating Manual Table 1 1 Key to Label Symbols Location of core sensor socket Loca
12. not attempt to increase more than 2 C above actual core temperature For Normothermia Mode Core temperature is less than 27 0 80 6 F Insert the core sensor into patient PATIENT TEMP ABOVE 38 5 C 101 39F Core temperature reading above 38 5 101 3 F Inform the physician MTRE amp CritiCool Pro Operating Manual Table 7 5 CritiCool Pro System Message Troubleshooting Guide cont Patient temp BELOW 27 09 80 6 lt Temp lt Inform the physician 35 5 C 35 5 C 95 99F 95 9 F ED Indicates alarm activated n Normothermia Mode Pressing Alarm Mute silences the buzzer for this present condition and any reoccurrence of this condition for thirty minutes Table 7 6 CritiCool Pro System Message Troubleshooting Guide cont Message Probable Cause Action to be Taken ATTENTION The CritiCool Pro device The message will disappear ELECTRO MAGNETIC detects an electromagnetic after ten seconds INTERFERENCE field greater than allowable t the message appears for 22 standard more than ten seconds replace the core sensor ATTENTION No surface sensor inserted Connect surface sensor to CONNECT SURFACE into the socket its socket SENSOR MTREG 7 7 Troubleshooting CritiCool Pro Operating Manual 7 8 MTRE amp CritiCool Pro Operating Manual CHAPTER 8 SPECIFICATIONS Physical Dimension
13. 4 Table 7 4 CritiCool Pro System Message Troubleshooting Guide 7 5 Table 7 5 CritiCool Pro System Message Troubleshooting Guide cont 7 6 Table 7 6 CritiCool Pro System Message Troubleshooting Guide cont 7 7 MTRE amp CritiCool Pro Operating Manual MTRE amp CritiCool Pro Operating Manual CHAPTER 1 SAFETY PRECAUTIONS Definitions WARNING indicates a condition that may endanger the patient or the system operator CAUTION indicates a condition that may damage the equipment NOTE indicates ways in which the system s operation can be made more efficient Intended Use The CritiCool Pro system is a thermal regulating system indicated for monitoring and controlling patient temperature Warnings physician must be notified if the patient s temperature does not respond properly does not reach the prescribed temperature or if there is any change in the prescribed temperature range Failure to inform the physician may result in injury to the patient e patient should be constantly attended by a physician e The misuse of the temperature regulation equipment can be potentially harmful to the patient Do not plug wet PL plugs of the human sensors into the sensor sockets of the CritiCool Pro device e The user should verify that no fluids are present at the skin Garment interface dur
14. CK CORE SENSOR D ATTENTION CHECK SURFACE SENSOR ATTENTION CONNECT CORE SENSOR D 8 2 MTRE CritiCool Pro Operating Manual ATTENTION WATER TEMP TOO LOW ED ATTENTION WATER TEMP TOO HIGH ATTENTION CORE READOUT LOW ATTENTION PATIENT TEMPERATURE ABOVE 38 5 C 101 3 F ED ATTENTION PATIENT TEMPERATURE BELOW 35 5 C 95 9 F ED ATTENTION ELECTROMAGNETIC INTERFERENCE ATTENTION CONNECT SURFACE SENSOR In Warming Mode Protection against electric shock Type BF Degree of protection against electric shock Class 1 Special mechanism Prevents extremely high pressure and temperature Quick coupling connectors Prevent leakage Anti current overload system 6 3 amp fuse CritiCool Pro device shutdown mechanism Software failure Accessories e Connecting tubes for CureWrap e Connecting tubes for ThermoWrap e Connector for draining the water tank Power cable e Spare filter Sensors 4 PL Stereo Phone Plug e Reusable core e Reusable surface MTRE 8 3 Specifications CritiCool Pro Operating Manual e Reusable infant core e Disposable adapter core e Disposable adapter surface Garment e Various Garment types e Sizes range from 40 cm 196 cm 1 4 6 5 8 4 CritiCool Pro Operating Manual APPENDIX MTRE CUSTOMER SERVICE REPRESENTATIVE IMPORTANT The following details are necessary to contact your MTRE repre sentative Keep this form with t
15. CritiCool Pro is now ready for storage until next procedure MTREG CritiCool Pro Operating Manual Turning Off the System MTRE amp gt To turn off the system 1 10 11 At the end of treatment turn off the CritiCool Pro device pressing the ON OFF switch downwards to the OFF position and disconnecting the power cord from the power source Close the clamps on the connecting tubes to avoid returning water overflow Disconnect the connecting tubes from the CritiCool Pro device and from the Garment Disconnect the core and surface sensors from the CritiCool Prodevice Remove the Garment and the sensors from the patient Dispose of the Garment in accordance with national regulations governing non toxic plastic waste discharge Disinfect the surface of the connecting tubes and the exterior of the CritiCool Pro device with a wet cloth soaked in 70 alcohol Dispose of disposable sensors or disinfect the reusable sensors and disposable sensor adapters as required by hospital clinic protocol Empty the water from the CritiCool Pro using the Empty procedure Press the brake pedals and lock the wheels to secure the CritiCool Pro device Store the CritiCool Pro device and its accessories in a safe place Operating Instructions 4 18 CritiCool Pro Operating Manual MTRE amp CritiCool Pro Operating Manual CHAPTER 5 ORDERING INFORMATION This section outlines information for ordering shipping and repl
16. Disposable Sen sor Adapters Use the Ethylene Oxide Method E T O to sterilize reusable sensors and disposable sensor adapters as reguired by hospital clinic protocol MTRE amp 6 1 Maintenance CritiCool Pro Operating Manual CAUTION not use the steam autoclave method to sterilize reusable sensors and disposable sensor adapters Cleaning and Disinfecting Procedures for Reusable Sensors Cleaning Probes should be cleaned with a mild detergent and water to remove excess bio burden and improve the effectiveness of disinfecting and sterilization Disinfecting e For low level cleaning use glutaraldehyde e For high level cleaning use Cidex glutaraldehyde dilute bleach 70 isopropyl alcohol Filter Replacement Note NOTE An additional filter is supplied in the accessory box The filter must be replaced every twelve months gt replacement the filter by the hospital personnel 1 Drain the water tank see Table 7 1 on page 7 2 2 Remove the rear cover 3 Unscrew the thumb captive screws at the bottom of the cover 4 Pull the bottom part of the cover towards you and then down to release the lip from the chassis Unscrew the filter clamp screw and remove the filter clamp see Figure 6 2 6 Release both the water in and water out tubes from the filter assembly by pressing the release ring of each end of the filter and pulling the tubes from the filter 7 Dispose of the old filter
17. MTRE CritiCool Pro Operating Manual The Automatic Re Warm Process MTRE amp The Re Warm process starts with the hypothermia temperature for example 33 5 C the first step of the process is to increase the virtual Set Point by 0 29C 33 5 0 2 33 79C for a period of 30 minutes Assuming that at the end of the 30 minutes period the Core temperature has reached for example 33 6 C the Re Warm algorithm adds 0 29C to the current Core temperature and the new virtual set point is now 33 6 0 2 33 8 C for additional 30 minutes and so on until the Core temperatures reaches the Target temperature At this point the process stops and the system changes the mode to Cooling mode with the Set Point equal to the Target temperature Note that the step delta temperature of the virtual set point is from the Core temperature that was achieve at the end of the step period and not from the last virtual set point To Start Automatic Re Warm 1 Use CC Menu key to open the Set Mode panel and change the mode from Cooling to Re Warm see Selecting Modes on page 4 6 Note In the automatic Re Warm mode the set point display changes to Target Temperature with a default of 36 5 C 2 Use the Target Temperature Setting panel see Target Temperature Setting on page 4 9 if you need to change the default target temperature Note The Target temperature is the temperature at which the automatic Re Warm
18. MTRE Ltd considers itself responsible for the effects on safety reliability and performance of the eguipment only if Repairs are carried out by authorized MTRE personnel only Electrical installation of the room in which the system is installed complies with all aspects of the relevant internationally recognized electrical safety standards as well as specific hospital reguirements The eguipment is used in accordance with instructions for use MTRE is not responsible for any consequential or incidental damages or expenses of any kind impairment of or damage to other goods or to any third party resulting from loss of use of the system caused by or due to the following a Installed operated maintained contrary to MTRE s instructions notes or warnings under this manual b Misuse unauthorized use negligence accident including fire water explosion smoke vandalism etc c Ignoring any of the warnings precautions and safety measures indicated in this manual d Replace repair or alter not by MTRE s authorized personnel e Anyone other than MTRE S authorized and certified personnel removes casing and or attempts to make or makes any internal changes removals attachments or additions to the CritiCool Pro System or components thereof 2 MTRE amp CritiCool Pro Operating Manual f The power supplied to the System or any part thereof differs from the rated value or any external device attached by user creates condition
19. UG ay ee 4 16 Empty Modes eca cA ie ene awd Siw eee 4 16 Tuming Off the System MES Gee DNAS RES QUERN NOE 4 17 Chapter 5 Ordering Information 5 55 5 ARE RSA IEDR ORS 5 1 Equipment and Accessories Ordering Information 5 1 Equipment and Accessories Inventory 5 1 Available Garments acd ca we Hoek pee ea 5 1 Chapter 6 CC 6 1 pita da stets e rue eai 6 1 Service om 2 o A az Lt 6 1 Routine Maintenance 4 15 2 azi edet 6 1 Sterilization of Reusable Sensors and Disposable Sensor Adapters 6 1 Cleaning and Disinfecting Procedures for Reusable 6 2 Cleaning xs axes tag Ea MEM SE IV REA SUE ES 6 2 Disinfecting 6 2 ILI1IL6ILI C0I C6I060L 25 A 0 6 2 MTRE amp CritiCool Pro Operating Manual Chapter 7 Troubleshooting 7 1 scs ROI YN 7 1 Trouble shooting Guide eee aes Oe ERE A RU 7 1 Chapter 8 Specificatlols AEG EYDAU ORC ERE AUD RUN 8 1 Physical 43i e nas nna Sena E OC
20. acing parts of the CritiCool Pro system Equipment and Accessories Ordering Information All equipment and accessories may be ordered directly from your local MTRE representative When ordering parts specify the model number as listed in this chapter as well as the serial number of your CritiCool Pro device Equipment and Accessories Inventory Available Garments MTRE Models for various garments are available Refer to Table 5 1 Table 5 1 CureWrap Sizes Table of CureWrap Sizes Part Height Width Garment Patient Patient Number Meter Meter Area Height In Height sq m Inches 3500 2 030 1 354 2 324 All adults sizes 3548 1 582 1 193 1 399 48 53 3541 1 390 1 054 1 089 41 48 3536 1 225 0 841 0 763 36 41 3531 1 118 0 740 0 637 31 36 3525 0 981 0 628 0 425 25 31 7 11 kg 3521 0 698 0 602 0 347 21 25 4 7 kg 3518 0 659 0 448 0 219 18 21 4 Kg For use only outside the USA 5 1 Ordering Information 5 2 CritiCool Pro Operating Manual Table 5 2 Accessories Inventory Part No Description 007 00365 Handle 200 00147 CureWrap Connecting tubes 200 00109 Connecting tubes 002 00069 Male connector for draining water tank 200 00130 Spare water filter 014 00020 Core sensor Gray 014 00021 Surface sensor Green 014 00028 Core sensor adapter Gray 014 00029 Surface sensor adapter Green 014
21. agents trained by MTRE Advanced Technologies LTD Precautions Follow the warning notes listed in the various sections of this manual Only trained personnel familiar with all system operating procedures and certified only by MTRE Advanced Technologies Ltd or authorized agents of MTRE Advanced Technologies Ltd are allowed to use the CritiCool Pro system All hospital personnel using the CritiCool Pro system must complete the CritiCool Pro training program The repair and servicing of the CritiCool Pro device should be performed only by qualified medical equipment service technicians certified by MTRE Advanced Technologies Ltd or authorized agents of MTRE Advanced Technologies Ltd If moisture or leaks are discovered in the connecting hose and or Garment turn off the CritiCool Pro device disconnect the power cable from its power source and correct the problem before proceeding The desired set point temperature should be fixed only as prescribed by and under the order of a physician If the device sounds an alarm and or presents a display other than the standard MTRE display the operator should proceed according to the display message MTRE CritiCool Pro Operating Manual and or the troubleshooting instructions see Chapter 7 Troubleshooting Avoid folds in the Garment these may obstruct water flow Do not block the CritiCool Pro device ventilation grilles Air must be able to flow freely in and out in order to keep the
22. aintains and reverses hypothermia in an effective and precise manner The desired temperature is preset by the physician with a possible range of target temperature from Hypothermia to Normothermia CritiCool Pro is member of MTRE s product family of body temperature control systems Allon 2001 CritiCool and CritiCool Pro including ThermoWraps CureWraps and accessories The system is composed of two elements the CritiCool Pro device and the CureWrap garment The CritiCool Pro device functions as a control unit and a cooling heating pump which circulates water The control unit constantly monitors the Patients core temperature through specific sensors and using its on board body temperature control algorithm delivers the optimum water temperature to reach the desired set point temperature The cooling heating pump brings the water to the reguired temperature and the pump circulates it through the specially designed CureWrap The CureWrap is a flexible 3D single piece design through which the water circulates It is designed to be in close contact with a large contact area of the body thus allowing optimization of energy transfer CritiCool Pro System The CritiCool Pro system consists of the following elements CritiCool Pro device MTRE amp 2 1 System Description CritiCool Pro Operating Manual Garment e Accessories e VitaLogik monitor CritiCool Pro Device The CritiCool Pro device has a microprocessor that c
23. an select control panel units to be either Centigrade or Fahrenheit 6 Select the Patient Type Adult or Neonatal Select default Settings values for Set Point Temp and Target Temperature and default values for automatic Re Warming mode according to the Patient Type MTREG 4 3 Operating Instructions CritiCool Pro Operating Manual Turning on the System WARNING The patient must be under constant supervision The misuse of temperature regulation equipment can potentially injure a patient gt Toturn on the system 1 Turn the main switch on the CritiCool Pro system located in the rear of the unit upwards to the ON position 2 Turnon the VitaLogikPatient monitor The patient information is displayed on the monitor SARA BED 1 9 12 09 16 13 Neonatal Cooling 2 0 8 0 H Com Temperatu m 100 50 5 Event Full Figure 4 2 Full Screen monitor display 1 215 100 5 4 4 MTRE CritiCool Pro Operating Manual Self Test Once power is supplied to the CritiCool Pro device the unit performs self test During the self test the control panel presents the message CritiCool Pro NO Cooling Therapy Control Panel After completion of the Self Test the Cooling Therapy Control Panel appears Mode Cooling Flow Alarm Icon Icon Icon Neonatal Cooling f xa Core Temperature Set Point Surface Temp Operate BS Tc Messages Area Figure 4 3 Thermoregulation Control Pa
24. anual Power cable e VitaLogik 4000 4500 monitor User s manual e Quick Reference Guide the Unit Preparation Before moving the unit 1 Ensure that the CritiCool Pro device is off by pressing the ON OFF switch 2 Ensure that all electrical connections are disconnected Locking and Unlocking the Trolley Wheels Storage Storage MTREG The CritiCool Pro device trolley has four wheels The front wheels are fitted with a brake The brake lever is located over the wheel To lock the wheels firmly press the lever To release the wheels lift the lever When the unit is stationary the brakes must be in the locked position Release the brakes only when transporting the unit Conditions and Transport CAUTION Use protective means to avoid excessive vibration during device transport Store the CritiCool Pro device in a clean and dry area with An ambient temperature of 40 C to 70 C 40 F to 158 F e A relative humidity range of 10 to 100 An atmospheric pressure range of 500 hPa to 1060 hPa The CritiCool Pro device features a utility bracket in the rear for storage of the connecting tubes and sensors when not in use 3 3 Installation 3 4 CritiCool Pro Operating Manual MTRE amp CritiCool Pro Operating Manual CHAPTER 4 OPERATING INSTRUCTIONS General This chapter contains description of the controls indicators and connections for the CritiCool Pro device e
25. e Set Point Setting panel Figure 4 5 MTRE 4 7 Operating Instructions CritiCool Pro Operating Manual SARA BED 1 EE Set Point Setting N Figure 4 5 Set Point Setting Panel 2 Use the Ouickey or touch optional to select the reguired set point 3 Click Main Screen to accept 4 8 MTRE CritiCool Pro Operating Manual Target Temperature Setting The Target Temperature Setting option enables seleting the re warming target temperature and is available only in Re Warm mode The default Target Temperature for Re Warm is 36 5 C 97 7 F gt To change the Target temperature 1 Use the CC Menu key to open the Set point panel SARA BED 1 Main Screen Target Temperature Setting Figure 4 6 Target Temperature Setting Panel 2 Use the Ouickey or touch optional to select the reguired target temperature 3 Click Main Screen to accept MTRE amp 4 9 Operating Instructions CritiCool Pro Operating Manual Re Warm Setup The Re Warm Setup panel provides control over the temperature steps during re warming and the duration of each step Re warm Settings Neonatal Re Warm Rate 0 2 C 30 Minutes Core Temperature m X Target Temp Operate Figure 4 7 Re warm Mode The default step and duration for Neonate is 0 2 C and 30 seconds and for Adult 0 2 C and 60 seconds Note This panel is accessible only in Re Warm mode gt To change the Re Warm settings 1 Usethe CC
26. efore shipment and should be operational upon delivery The unit should be unpacked installed and tested only by MTRE s authorized personnel No attempt should be made by the purchaser to unpack or assemble the unit alone Note Report any container damage prior to opening the container or any unit damage prior to unpacking installation or testing to your MTRE distributor Assembling the Handle gt Toassemble the handle Release the four thumb screws by hand MTREG 3 1 Installation CritiCool Pro Operating Manual Slide the two ends of the handle into the holes in the top cover pay attention to the direction of the curve in the handle until the handle is inserted all the way in see Handle Assembly3 1 Press in and screw the four thumb screws by hand do not use force when screwing to secure the handle and the top cover Thumb Screws Figure 3 1 Handle Assembly Eguipment List The CritiCool Pro system includes the following CritiCool Pro device Connecting tubes for ThermoWrap Connecting tubes for CureWrap Special connector for draining the water tank Reusable core sensor for 230V system Reusable surface sensor for 230V system Reusable infant core sensor ordered separately for 230V system Disposable core sensor adapter for 120V system Disposable surface sensor adapter for 120V system Handle Spare Filter MTRE amp CritiCool Pro Moving Operating M
27. further clarification The information provided in this manual is not intended to replace regular medical training procedures This manual should always accompany the system All gualified personnel operating the system should know the location of the manual For additional copies of this manual please contact your MTRE representative CritiCool Pro Operating Manual MTRE amp CritiCool Pro Operating Manual TABLE OF CONTENTS Chapter 1 Safety Precautions 1 1 1 1 Intended Use ac Pda D EF 1 1 Wales 1 1 Precauwon Mined eae AD OUD OU dere iren daa 1 2 USE MO dart 1 3 Labels E ages 1 4 CritiCool Pro Device Labels Bat DOG 1 4 Chapter 2 System DOeScFIDIUDHA 2 1 General DescEIDUOD sce e eee ra s hie vec deer pa biu e de ac 2 1 CritiCool Pro System as cx pas Dd GR a ax 2 1 CriiCool Pro Devices FEYDD 2 2 External Features 2 2 Front View 2 2 Side View 2 3 Rear Panel e Bd po a a adu 2 4 Garments ahah p a ae aaa
28. he User s Manual for easy access in case your CritiCool Pro device is in need of service Representative Name Company Name Address Telephone No Fax E mail MTRE amp A 1 MTRE Customer Service Representative A 2 CritiCool Pro Operating Manual MTRE amp
29. his message indicates that the core temperature is 2 C below the desired set point see Warning in Section Changing the Set Point Temperature When the core sensor is inserted into the patient the sensors read the patient s body temperature and the message clears Warming Mode MTRE amp Use the Warming mode for warming a patient in order to reach Normothermia following accidental hypothermia or to manually re warm the patient at the end of hypothermia treatment period Note The CritiCool Pro device is automatically pre set for Cooling therapy The device can be set to operate in Warming mode see Selecting Modes on page 4 6 To manually re warm the patient select a set point that is slightly above the core temperature see Set Point Setting on page 4 7 and wait until Core temperature 4 13 Operating Instructions CritiCool Operating Manual reaches the new set point increase the set point another step and wait for the core temperature to reach the next step Repeat the procedure until the patient reaches normal temperature The set point step and the duration at each step depend on the hospital treatment policy WARNING When warming the patient always choose setpoint temperature that is no more than 2 C 3 6 F above the core temperature Otherwise the CritiCool Pro device ignores the set point and con tinues cooling WARNING The desired set point temperature should only be set by the ph
30. ing Re Warming after therapeutic hypothermia must be gradual This mode provides controlled gradual warming Each step of the procedure increases the set point temperature by a fixed small step for a predefined period step is always related to the Core temperature reached at the end of the previous stage The user has to set only the final Target temperature Standby During Standby mode the system measures patient temperatures without water flowing through the Garments and or temperature regulation Empty 4 6 Use this mode to empty the system from water prior of storage of the CritiCool Pro MTRE amp CritiCool Pro Operating Manual gt To select a mode 1 Press the CC Menu key 2 Select the Set Mode option to display the Set Mode panel SARA BED 1 Main Screen CritiCool Mode Cooling v Re Warm Empty Standby Figure 4 4 CritiCool Pro Mode selection panel 3 Use the Quickey to select the required mode The selected mode is marked by a green dot 4 Click Main Screen to activate the mode Note The selected mode is show on the top of the control panel see Figure 4 3 Set Point Setting The Set Point is the temperature to which the thermoregulation system is cooling or warming the patient s body The set point default for cooling is 33 5 C 92 3 F for neonates and 33 0 C 91 4 F for adult gt To change the set point temperature 1 Use the CC Menu key to open th
31. ing the treatment Failure to do so can cause lesions on the patient s skin Following the procedure a pattern resembling the Garment may appear for a short period of time on the patient s skin e In procedures that usually extend over two hours pressure sores may appear or develop when soft tissue is compressed between a bony prominence and external surface The use of the CritiCool Pro system does not prevent this occurrence MTRE 1 1 Safety Precautions CritiCool Pro Operating Manual Before initiating maintenance procedures as described in Chapter 6 disconnect the power cord from the power source The default setting is intended to induce hypothermia system provides the physician with the option of selecting a body temperature in the range of 30 C to 40 C 86 F 104 F Do not lift or move the patient by means of the Garment This may cause tearing and water leakage Use reusable core sensors or disposable sensor adapters supplied by MTRE or YSI series 400 compatible sensors The technical principles clinical applications and risks associated with circulatory support must be thoroughly understood before using this product Read the entire manual before attempting to activate the system Completion of the training program prior to using the CritiCool Pro system is mandatory The repair calibration and servicing of the CritiCool Pro system should be performed only by MTRE Advanced Technologies LTD or authorized
32. k The garment was accidentally punctured during the course of the operation Turn off the CritiCool Pro device and allow the water to return to the reservoir Replace the Garment if possible Water leaks from the connector between Garment and the connecting tube Connecting tubes are not connected properly Close clamps on Garment Disconnect connecting tubes and re connect connecting tubes until the click sound is heard Damage to connecting tubes Replace connecting tubes Damage to Ouick Coupling Connector Call BMD Water leaks between connecting tubes and the CritiCool Pro device Connecting tubes are not connected properly Disconnect connecting tubes from the machine and re connect again Damage to connecting tubes Replace connecting tubes Damage to Ouick coupling connector Call BMD MTRE amp CritiCool Pro Operating Manual Table 7 2 CritiCool Pro System Undisplayed Malfunction Troubleshooting Guide cont Observation Action to be Taken Water tank overfilled If it is necessary to drain the water tank because of overfilling proceed as follows 1 Connect one end of the ThermoWrap connecting tube to the right Ouick Coupling Connector under the Core Sensor socket or Connect the gray coded end of the CureWrap connecting tube to the right Ouick Coupling Connector under the Core Sensor socket 2 Connect the s
33. mber of Mennen Medical Group AMIRE Wr Thermoregulation System USER MANUAL DDT 136 007 Rev A January 2010 0473 Conformity according to the Council Directive 93 42 EEC concerning Medical Devices Manufacturer s Name Mennen Medical Ltd 4 Hayarden Street Yavne 81228 P O Box 102 Rehovot 76100 Israel Tel 972 8 9323333 Fax 972 8 9328510 European Representative Charter Kontron Limited Unit 18 Avant Business Centre 21 Denbigh Road Milton Keynes MK1 1DT England Tel 01908 646070 Fax 01908 646030 Publication No DDT 136 007 Rev A Revision January 2010 Copyright 2010 by MTRE All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders CritiCool Pro Operating Manual Important Notice This document is delivered subject to the following conditions and restrictions All rights reserved No part of this manual may be reproduced or copied in any form by any graphic electronic or mechanical means including photocopying scanning typing or information retrieval systems without advanced written permission from MTRE Ltd U S Patent No 6 500 200 BI Trademarks CritiCool Pro is a trademark of MTRE Ltd Other company and brand product and service names are for identification purposes only and may be trademarks or registered trademarks of their respective holders Data is subject to change without notice Responsibility of Manufacturer
34. nel The Control panel shows the patients Core and Surface temperatures the Set Point temperature a Cooling icon that indicates that the system is cooling the water and a moving Flow icon that indicates that water is flowing through the Garment Note Use the Alarm icon to mute the audible alarm Alarm and warning messages are displayed at the lower part of the panel Use the Ouickey or Touch Screen Optional to reach the control panels and keys Use the CC Menu key to open the thermoregulation menu The menu consists of the following Set Mode Select the operating mode MTRE amp 4 5 Operating Instructions CritiCool Operating Manual e Set Point Setting Set the temperature to which the thermoregulation system 15 cooling warming the patient s body Target Temperature Setting Set the target temperature for rewarm mode e Re Warm Setup Setup the warm up procedure Activate Selecting Modes The following modes are available e Warming e Cooling Re Warm Standby Empty Warming In this mode the system warms the water to prepare the system for patient warming The set point is selected and the temperature control is activated to warm the patient and prevent hypothermia Set point is limited to maximum 27C above Core temperature Cooling In this mode the system cools the water to prepare the system for patient cooling in attempt to achieve mild hypothermia Re Warm
35. ng Surface Sensor Attach the reusable surface sensor or the disposable surface sensor to an exposed area of skin with adhesive tape Immediately connect the disposable surface sensor to its adapter WARNING When using disposable sensors and adapters make sure to con nect the appropriate sensor to its adapter note the labeling on the adapter MTREG 4 11 Operating Instructions CritiCool Pro Operating Manual Fastening Garment to Patient Refer to the Instructions for Use leaflet supplied with each Garment CAUTION If treatment exceeds the allowed lifetime as indicated in the leaflet replace the garment Sustaining treatment for extended periods may result in skin wetting Replacing the Garment gt To replace the Garment Use the CC Main menu to open the mode panel Select STAND BY mode Close garment clamps to avoid water spill 1 2 3 4 Disconnect the connecting tubes from Garment 5 Remove the used Garment and dispose according to hospital regulations 6 Place the new Garment follow the Instructions for Use leaflet supplied with each Garment 7 Fill the Water Tank with tap water to required level 8 Reconnect the connecting tubes to the new Garment 9 Fill the new Garment by water 10 The system is ready for treatment Cooling Mode After completing the self test the CritiCool Pro device shifts into the operation mode the default mode is Cooling The default temperature is 33
36. ng to hospital policy Note The Garment contains chlorine tablets Cl that prevent contamination of the hydraulic system of the CritiCool Pro system MTRE amp CritiCool Pro Operating Manual CHAPTER 7 TROUBLESHOOTING General The CritiCool Pro device is eguipped with self testing routines that continuously monitor system operation If a system fault or malfunction is detected a fault message appears on the message display Should a malfunction occur consult the Troubleshooting Guide in 7 1 and 7 2 of this chapter Trouble shooting Guide MTRE amp 7 1 lists some possible symptoms that indicate malfunctions that do not appear on the message display their cause and recommended actions provides a list of fault messages that appear on the CritiCool Pro device screen WARNING _ The repair and servicing of the CritiCool Pro system should be performed only by MTRE Advanced Technologies Ltd or autho rized agents of MTRE Advanced Technologies Ltd 7 1 Troubleshooting 7 2 CritiCool Pro Operating Manual Table 7 1 CritiCool Pro System Undisplayed Malfunction Troubleshooting Guide Observation Possible Problem Action to be Taken The power switch of the CritiCool Pro device is set to but it is not activated and the control panel is blank CritiCool Pro device is unplugged Check the 120 230 VAC power cable connections No line voltage Call BMD Garment begins to lea
37. nsors and adapters are guaranteed for one year WARNING Use reusable core sensors or disposable sensor adapters sup plied by MTRE or YSI series 400 compatible sensors Reusable Core Sensor Part No 014 00020 The core sensor gray measures core body temperature when inserted into the patient s body The PL plug of the sensor cable is plugged into the gray core sensor socket at the front of the CritiCool Pro device The other end is inserted into the patient and measures core body temperature Disposable Core Sensor Adapter Part No 014 00028 The disposable sensor is attached to the core sensor adapter gray The PL plug of the adapter is plugged into the gray core sensor socket at the front of the CritiCool Pro Device The sensor is inserted into the patient and measures core body temperature Reusable Infant Core Sensor Part No 014 00005 The infant core sensor gray measures infant core body temperature when inserted into the patient s body The PL plug of the sensor cable is plugged into the gray core sensor socket at the front of the CritiCool Pro device The other end is inserted into the patient and measures core body temperature Reusable Surface Sensor Part No 014 00021 The surface sensor green measures body surface temperature when attached to the patient s skin The PL plug of the sensor cable is plugged into the green surface sensor socket at the front of the CritiCool Pro device The other end is attached
38. ontrols the water temperature flowing into the Garment worn by the patient The decision as to the correct water temperature is based on the desired set point temperature and the actual measured patient temperature core and surface Water pressure in the Garment is regulated by timed pauses of the flow during clinical operation The CritiCool Pro device is equipped with a handle for easy transport External Features Front View Adjustable Control Panel Surface Sensor A Core Sensor Socket V e amp Socket Water in en a Water out Guick Coupling Quick Coupling Connector Connector Water Level Indicator Ld Water Tank Cap Figure 2 1 Front View 2 2 MTRE amp MTRE amp CritiCool Pro Operating Manual Side View Top Cover with Air Grille Accessories Bracket 9 Lower Side Cover Air Inlet Grille Figure 2 2 Side View System Description CritiCool Pro Operating Manual Rear Panel Thumb Screws 4 Three prong Air Outlet Grille Connector RS 232 Comm Connector Equipotentiality Location Figu
39. pecial male connector to the connecting tube For ThermoWrap see ThermoWrap Connecting Tubes and Special Male Connector7 1 or For CureWrap see 7 CureWrap Connecting Tubes and Special Male Connector2 Turn the CritiCool Pro device ON Change into Operation mode Allow the excess water to drain into a receptacle pail or sink When the desired water level has been reached turn the CritiCool Pro device OFF o o o Special Male Connector for Draining Water Tank Figure 7 1 ThermoWrap Connecting Tubes and Special Male Connector MTRE amp 7 3 Troubleshooting CritiCool Pro Operating Manual Table 7 2 CritiCool Pro System Undisplayed Malfunction Troubleshooting Guide cont Special Male Connector for Draining Water Tank Figure 7 2 CureWrap Connecting Tubes and Special Male Connector Note Note A muted alarm is activated when subseguent message appears The Halt Please Restart message indicates an error that can have numerous causes You must restart the CritiCool Pro device Table 7 3 CritiCool Pro System Message Troubleshooting Guide Message Probable Cause Action to be Taken HALT PLEASE RESTART ED XX Error during normal function Turn OFF the system for 3 seconds and then turn it ON again If the problem persists turn OFF the CritiCool Pro device and contact your local service representative Note the number that appea
40. process will end 3 Click Operate to start Re Warming Neonatal Re Warm Rate 0 2 C 30 Minutes Core Temperature r1 X Target Temp Flow Icon Click to start Operate The CritiCool Pro heats the water and starts circulation The flow icon starts to rotate The system proceeds to increase the virtual set point until the Target temperature is reached When Core temperature reaches the Target temperature the mode automati cally changes to Cooling with the set point equal to the Target Temperature and the 4 15 Operating Instructions CritiCool Pro Operating Manual CritiCool Pro stabilzes the body temperature at the normothermia STAND BY Mode STAND BY mode is used only to monitor body temperature The CritiCool Pro Device circulates the water internally and maintains the water temperature at the appropriate level to be ready when returning to Cooling or Warming mode Standby Core Temperature Set Point Surface Temp Operate Be I Note Note During STAND BY mode there is no temperature regulation Use this mode when replacing a Garment Empty Mode 4 16 Before storing the system you have to empty the water from the CritiCool Pro To empty the water 1 Disconnect the garment 2 Connectan emptying tube to the water out of the CritiCool Pro and direct the tube to a bucket for water collection 3 Change the mode to Empty 4 Wait for all the water to come out of the system The
41. re 2 3 Rear View Garment General The Garment is a one piece garment with a one inflow and a one or two return water connection It is designed to facilitate the wrapping of individual parts of the body chest arms thighs etc to maximize surface coverage Description and Intended Use The Garment 15 e Disposable e Biocompatible Latex free 2 4 MTRE CritiCool Pro Operating Manual e Antistatic Inflatable e Adjustable Each section of the Garment is separately wrapped around the appropriate area of the patient e g chest arms and thighs to ensure maximum body surface coverage The water s exit and entrance points are short sections of tubing integrated with a Quick Coupling Connector QCC and welded to convenient locations on the edges of the Garment The Garment design allows the physician user to cover a maximum surface area as needed The Garment is secured to the patient via hook and loop strips or pressure sensitive adhesive strips Selected Garment Design MTRE Advanced Technologies Ltd offers disposable Garments in a wide range of sizes There are three different Garment designs CureWrap e Material Patient side Non Woven PP Avgol Ltd Water Barrier Film Appelton MPE Grade 56606 Exterior side Frontal Tape FT 600 Usage duration 72 hours Fastening method Velcro unlimited repeated use CAUTION Select the garment according to the patient s size MTRE amp 2 5
42. rs on the screen 1 16 ATTENTION NO WATER PLEASE ADD WATER No water in tank Refill water to maximum level Water tank float is jammed Open water tank cap and insert a long object to release the float MTRE CritiCool Pro Operating Manual Table 7 3 CritiCool Pro System Message Troubleshooting Guide ATTENTION OUT OF NORMOTHERMIA PRESS OK TO CONFIRM For Cooling Therapy Desired set point is set to exceed 38 For Normothermia Mode Desired set point is set to be out of 369C 38 C Approve the action Disapprove the action ED Indicates alarm activated Table 7 4 CritiCool Pro System Message Troubleshooting Guide cont CD Message Probable Cause Action to be Taken ATTENTION For Normothermia Mode Connect water connection to WATER While self test was system and garment CONNECTIONS performed no water connection were attached ATTENTION Connecting tubes are not Connect connecting tubes CHECK WATER connected CONNECTIONS Garment is blocked due to improper wrapping Check for snarls folds or objects that obstruct the water flow in the Garment Garment clamps are closed Check clamps ATTENTION CHECK CORE SENSOR ED 11 Misplacement of sensor in core socket Connect the core sensor to the appropriate socket Core adapter is connected to the CritiCool Pro device without the disposable tempera
43. s 260 mm W x 625 mm D x 940 H 10 23 W x 24 6 D x 37 Net Weight 33 kg 77 lb Control System Micro controller Operating icons Set point switch and mode switch Displays e Core Temperature e Set point temperature e Alarm displays Surface Temperature Graphic display of core temperature Controller range e Water Temperature outflow 13 40 8 C 55 105 4 F e Set Point Temperature 30 40 C 86 104 F Sensors accuracy e Patient Temperature 0 3 C 0 4 F Water accuracy e Water Temperature 0 3 C 0 4 F Auxiliary Systems Water tank Maximum Volume 6 liters 1 6 gal MTRE 8 1 Specifications CritiCool Pro Operating Manual Warranty One year Operation Ambient Temperature 109C 40 C 50 F 104 F Storage and Transport without Water Control CritiCool Pro Device e Maximum storage time is 26 weeks An ambient temperature range of 40 C to 70 C 40 F to 158 e relative humidity range of 10 to 100 n An atmospheric pressure range of 500 hPa to 1060 hPa Electricity Input power 230 115 VAC with isolation transformer 50 60 Hz Maximum Current 230 115 VAC 6 3 amp Transformer Medical multiple isolation transformer 230 115 VAC Safety Warning displays indicates audible alarm SYSTEM HALT D ATTENTION NO WATER PLEASE ADD WATER ED ATTENTION OUT OF NORMOTHERMIA RANGE PRESS OK TO CONFIRM ATTENTION CHECK WATER CONNECTIONS ED ATTENTION CHE
44. s exceeding the tolerance of the System or g The use of accessories and other parts or equipment made by other manufacturers whether or not warranted by such manufacturers which have been attached or connected to the System after installation unless such accessories and other parts have been supplied and attached or installed by the MTRE h Using the system in a contrary manner than indicated in this manual or using the system for any purpose other than indicated in the manual i Failure to replace the Garment in each procedure while operating the system Note that all Garments are one use disposable materials and should not be reused j Force Majeure In no event shall MTRE be liable for loss of use loss of profits or other collateral special or conseguential damages Use of Manual MTRE amp The MTRE CritiCool Pro system described in this manual has been designed to meet international safety and performance standards Only gualified personnel may operate the system and these operators must first have a full understanding of the proper operation of the system The purpose of this manual is to help gualified personnel understand and operate the system It is important that you read this manual and familiarize yourself thoroughly with its contents before you attempt to operate the system If you do not understand any part of this manual or if anything is unclear or ambiguous in any way please contact your MTRE representative for
45. t Preparing the System for Operation gt To prepare the system for operation 1 Place the unit in the desired position according to Space and Environmental Reguirements on page 3 1 2 Press the brake pedals and lock the wheels to secure the CritiCool Pro device 3 Remove the water tank feeder cover and pour in fap water until the maximum allowable level is reached Observe the water level indicator to prevent overfilling the water tank Close the water tank feeder cover In case of overfilling see Table 7 1 4 Connect the CritiCool Pro device and the VitaLogik monitor to the power source Turning on the System System Setup Before turning on the CritiCool Pro system you need to set up the system using the VitaLogik monitor 4 2 MTRE amp CritiCool Pro Operating Manual Note Refer to the VitaLogik User Manual for accessing the System Setup options gt setup CritiCool Pro On the VitaLogik monitor 1 Discharge the patient 2 Open the Main menu 3 Select Setup 4 Select System Setup Note Use of System Setup is password protected From the System Setup menu select Vital Signs Setup The Vital Signs menu is displayed 2 From the VS Setup menu select CritiCool Setup The CritiCool Setup dialog panel is displayed end F3490 Eu B35 365 o2 330 365 02 e Figure 4 1 CritiCool Setup in VitaLogik 5 From the Units drop down list select the temperature readout unit You c
46. te etes eee oana 4 4 Figure 4 3 Thermoregulation Control Panel pp 4 5 Figure 4 4 CritiCool Pro Mode selection panel pp 4 7 Figure 4 5 Set Point Setting Panel oe qd grae A ia ai a a ge 4 8 Figure 4 6 Target Temperature Setting Panel pp 4 9 Figure 4 7 Re wartn Mode eee a a d a al e d 4 10 Figure 4 8 Re Warm Setup Panel ta a at d aa 4 10 Figure 4 9 Alarm Message Core too I0CV I ai aa tul a ia aa 4 13 Figure 6 15 Filter Orientation una coat cat al ta iuf FC ai 6 3 Figure 6 2 Filter Assembly ju cui aa ae cee MR FAD AC AN 6 3 Figure 7 1 ThermoWrap Connecting Tubes and Special Male Connector 7 3 Figure 7 2 CureWrap Connecting Tubes and Special Male Connector 7 4 MTREG vii CritiCool Pro Operating Manual viii MTRE amp CritiCool Pro Operating Manual LIST OF TABLES Table 5 1 Cure Wrap 5168 9 5 1 Table 5 2 8 al tt at tie 5 2 Table 6 1 Inspection and Maintenance Schedule 2 6 4 Table 7 1 CritiCool Pro System Undisplayed Malfunction Troubleshooting Guide 7 2 Table 7 2 CritiCool Pro System Undisplayed Malfunction Troubleshooting Guide cont 7 3 Table 7 3 CritiCool Pro System Message Troubleshooting Guide RN 7
47. tion of surface sensor socket AC Voltage Fuse CE mark of conformity indicates that the product has received the European approval for MDD 93 42 EEC Equipment not suitable in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide Refer to user manual Type BF equipment Recycle MTRE amp 1 5 Safety Precautions CritiCool Pro Operating Manual Date of manufacture CSA symbol indicates that the product has received the approval of the SP Canadian Standards Association US XX Machine Version Machine serial number 1 6 MTREG CritiCool Pro Operating Manual CHAPTER 2 SYSTEM DESCRIPTION General Description A growing number of cases require a solution for controlling patient temperature in various hospital settings Inducing hypothermia or simply controlling fever is beneficial and sometimes vital The CritiCool Pro systems combines the thermal regulation capabilities of it s predecessor the CritiCool amp with the well known VitaLogik patient monitoring It provides integrated data storage of the thermal regulation and the clinical condition of the patient under going treatment The patient monitoring waveforms and numeric vital sign can be viewed on Mennen Medical Central Nurse Station the Ensemble and the Enguard if the CritiCool Pro is connected to the MennenNet The CritiCool Pro system induces m
48. to enable the flow of water between them The tubes are supplied as a paired unit with two male Quick Coupling Connectors at the CritiCool Pro device end and with two female Quick Coupling Connectors at the ThermoWrap end Male Connector for Draining Water Tank Part No 002 00069 Refer to Table 7 1 CritiCool Pro System Undisplayed Malfunction Troubleshooting Guide on page 7 1 Spare Water Filter Part No 200 00130 For annual filter replacement packed in the accessory box MTRE CritiCool Pro Operating Manual Handle Part No 007 00365 Interface cable between CritiCool Pro and the VitaLogik monitor Part number 641 345 090 MTRE amp 2 9 System Description 2 10 CritiCool Pro Operating Manual MTRE amp CritiCool Pro Operating Manual CHAPTER 3 INSTALLATION Pre installation Requirements Space and Environmental Requirements The CritiCool Pro device is supplied on a trolley as a mobile unit for user convenience It must be located no less than 5 cm 2 from other objects to avoid the impairing of ventilation to the CritiCool Pro device The following dimensions should be considered when placing the CritiCool Pro device 260 mm W x 625 mm D x 940 mm H 10 23 W x 24 6 D x 37 H Electrical Requirements 230 115VAC 500W CAUTION Verify that the voltage switch is set for the local voltage Unpacking and Inspection The CritiCool Pro device has undergone full quality assurance testing b
49. ture sensor Connect disposable sensor ATTENTION CHECK SURFACE SENSOR 12 Misplacement of sensor in surface socket Surface adapter is connected to the CritiCool Pro device without the disposable temperature sensor Connect the appropriate surface sensor to its socket Connect disposable sensor MTREG 7 5 Troubleshooting 7 6 CritiCool Pro Operating Manual Table 7 4 CritiCool Pro System Message Troubleshooting Guide cont ATTENTION CONNECT CORE SENSOR No core sensor inserted in its socket Connect core sensor E Indicates alarm activated The alarm is activated again after 30 minutes if no action is taken Table 7 5 CritiCool Pro System Message Troubleshooting Guide cont Message Probable Cause Action to be Taken ATTENTION Water Temperature Turn OFF the system for 3 WATER TEMP TOO 109C seconds and then turn it ON LOW CD 46 again If the problem persists turn OFF the CritiCool Pro device and contact your local Service representative ATTENTION WATER TEMP TOO HIGH ED 17 Water Temperature 429 Turn OFF the system for 3 seconds and then turn it ON again If the problem persists turn OFF the CritiCool Pro device and contact your local Service representative ATTENTION CORE READOUT TOO LOW CD For Cooling Therapy Core temperature is more than 29 below set point Re warming Do
50. ysi cian or under the order of a physician Normothermia Management To achieve Normothermia use Warming mode Set the temperature Set Point to the desired temperature The CritiCool Pro device automatically operates at the optimal level to obtain the desired set point temperature so that when in Warming mode the difference between the set point temperature and the core temperature does not affect the heating rate A further increase in the set point temperature will not affect the water temperature in the Garment For example if the core temperature is 36 C 96 8 F and the set point temperature is 37 C 98 6 F raising the set point temperature will not accelerate the heating of the water in the CritiCool Pro system Exceeding the Normothermia Range If the desired set point temperature is set to be out of Normothermia range 36 C 38 C 96 8 F 100 4 F the message Core too High check Core and Operate appears Re Warming Mode 4 14 This mode is used for automatic Re warming at the end of hypothermia treatment period In Re Warming mode the CritiCool Pro increases the set point automatically in small steps with a pre selected duration for each step The default temperature steps and their duration are defined in the System Setup password protected see Re Warm Setup on page 4 10 The default for neonatal is AT 0 2 C and t 30 minutes The default for adults is AT 0 2 C and t 60 minutes
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