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Service Manual

1. Part Number Description Controller board 300 00114 118 300 00114EX Exchange of Controller board Image not available TEC control board 300 00117 300 00117EX Exchange of TEC control board Image not available Human sensor board 300 00016 300 00016EX Exchange of Human sensor board 300 00015 Flow amp pressure board 300 00015EX Exchange of Flow amp pressure board MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Controller board TEC control board harnessx2 300 00098 300 00102 Controller board human sensor board harness 300 00100 Controller board flow amp pressure board harness 300 00099 MTRE Advanced Technologies Lid Thermoregulation Service Manual Part Number Description Controller board RS 232 connector harness 300 00101 Main harness right side 300 00050 Main harness left side 300 00051 B 20 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Level sensor harness 300 00091 Controller board pump harness 300 00080 Top panel assembly display amp cover 200 00062 MTRE Advanced Technologies Lid B 21 Thermoregulation Service Manual Part Number Description Water filter assembly 200 00130 Pump assembly 200 00115 Single thermistor unit ass
2. Pump The pump circulates water through the system at rates of 0 8 1 2 liters per minute The pump is a positive displacement type it builds up unlimited pressure at the pump output This pressure is limited in two stages e Pres 1 at 0 9bar Pres 2 at 1 8 bar safety The controller board controls the pump power supply by digital control ON OFF There is a Fast Acting fuse and a LED for the pump The pump works on 12V Machine Version 04 05 and 10V Machine Version 03 The pump operates at 1 8 bar for two minutes before being stopped at system halt For removal of the pump see Chapter 7 Hydraulic System Solenoid Bypass Valve The solenoid bypass valve directs the flow of water to the Garment or back to the water tank It is activated by the control signal from the controller board gt To remove the Solenoid Valve see Figure 6 17 1 Remove the handle and the top cover see Chapter 5 Panels and Covers 2 Open the right side cover 3 Disconnect the 8 mm flow tube to the water out assembly by pressing the release ring on the fitting 4 Disconnect the 8mm flow tube to the water tank 6 22 MTRE Advanced Technologies Lid Thermoregulation Service Manual 5 Disconnect the 8mm tube to the HCU 6 Disconnect the electrical control connection from the lower part of the solenoid with a bulldog Philips screwdriver 7 Unscrew the two Philips screws that secure the Solenoid Valve Bracket
3. Note The Thermostat input signal passes through a comparator on the Human Sensor board the comparator output Logic 0 or 1 activates the ATTENTION HALT PLEASE RESTART 3 warning Table 6 10 Human Sensor Board Connectors Identifier Type Description J10 DB15 Power supply from controller board output signals to controller board J1 0 25 stereo socket CORE input signal J5 0 25 stereo socket SURFACE input signal J4 Header 2 Water out temperature input signal J6 Header 2 Water in temperature input signal J7 Header 2 Thermostat input signal MTRE Advanced Technologies Lid 6 13 Electrical System Thermoregulation Service Manual Figure 6 9 Human Sensors Board Component Placement gt To remove the Human Sensors Board see Figure 6 10 I 2 3 6 14 Remove the handle and the top cover see Chapter 5 Panels and Covers Remove the MMI Cover see Chapter 5 Panels and Covers Remove the two Philips head screws and washers that connect the Human Sensors board to the bracket Detach the ribbon cable to the controller board by pressing the slide lock bracket Detach the Water in Water out and thermostat connectors Note To re assemble the Human Sensors board follow the above directions in reverse order Tighten the three hexagonal nuts to a torque of 80 90 Ncm with a 5 8 socket wrench MTRE Advanced Technologies Ltd Thermoregulation S
4. 3 Change the temperature value on the simulator according to Table 9 2 4 Surface measurement connect Surface cable between temperature simulators to the tested sensor socket 5 Change the temperature value on the simulator according to Table 9 2 Table 9 2 Verification Form Human Sensors using Temp Probe Simulator TP400017 00284 Temp C Max Min Surface C Core C Accept Failed 20 20 30 19 70 25 25 30 24 70 30 30 30 29 70 35 35 30 34 70 36 36 30 35 70 38 38 30 37 70 40 40 30 39 70 Water Temperature Sensors Verification The Water Temperature and Thermostat connectors are located on the Human sensors board Note Perform this test in one shift If the maximum water temperature measurements exceed the allowed tolerance 1 0 refill the water tank with fresh water gt To perform the Water Temperature sensors verification test 1 Add 1 5 liter of tap water to the water tank 2 Remove the handle and the top cover see Chapter 5 Panels and Covers 3 Turn the ON Thermoregulation device 9 4 MTRE Advanced Technologies Ltd Thermoregulation Service Manual A ES Scroll down to Operation Mode and press the Mode key to enter Change the set point temperature with the arrow keys to 400C Press Mode Scroll down to Technician Mode and press the Mode key to enter Connect the Temperature Calibration Unit P N 017 00184 or P N 017 00284 with the Core Calibratio
5. Due to continuing product innovation specifications in this List as well as Typos are subject to change without notice Company shall not be liable for delays or for failure to manufacture and or deliver due to causes beyond its reasonable control or due to compliance with any government regulations Spare Parts Prices are provided by MTRE Service Department Always use the Service Call Form for reporting on failures assistance request and Price Requests Upon Receiving a Board for Exchange EX You should send back the Faulty one Freight Prepaid to the Factory within 30 Days CritiCool Cooling Control Unit Figure B 1 CritiCool Control Unit MTRE Advanced Technologies Ltd B 1 Thermoregulation Service Manual e Non Invasive approach to Cooling Therapy e Precise Temperature Control e Maximal Energy Transfer e Early Treatment Initiation e Minimal Staff Labor e Pressure relief algorithm e Optimal Patient Surface Coverage e Unique Heat removal Approach e Body Shaped 3 Dimentional CureWrap Garment for Intuitive use e Latex Free CureWrap with Simultaneous Water Flow through Numerous Channels Provides Superior Heat Exchange Capacity e Biocompatible Latex Free and Anti Static CureWrap Suits any Hospital Setting e Includes Control Unit CureWrap Connecting tubes ThermoWrap Connecting Tubes Spare Water Filter Core amp Surface Temperature Sensors Drain Water Tank Connector User Manual Criti
6. Regulatory CE 0473 FDA Clearance K102112 EN 60601 1 EN 60601 1 2 Type BF Degree of protection against electrical shock MTRE Advanced Technologies Ltd All rights reserved Specification subject to changes without notice AMIRE Hardware and Parameters VitaLogik 4000 4500 is a compact monitor with a built in 12 1 display and battery back up Available in two versions VitaLogik 4000 Non Invasive monitor e 3 5 12 lead ECG Respiration NIBP SpO2 Masimo Nellcor 2 Temperatures VitaLogik 4500 Invasive monitor 3 5 12 lead ECG Respiration NIBP SpO2 Masimo Nellcor 2 Temperatures 2 x IBP optional 4 IBP available CO 2 additional Temperatures Both versions offer Microstream EtCO2 optional Anesthetic Gases supported via UIM Port 2 x Universal Input Module UIM Either 4 channels Analog output or Remote control Integrated 3 Channel Recorder optional External Video Output Universal Input Module UIM e 2x RS232 ports e Interface to other vendor devices A4800 EVITA BISx Vigilance Matisse Saturn Evo IRMA CritiCool CPU Details Via X86 Core Fusion CPU Sound Blaster 2W audio power 4Q Mass storage 1 GB compact flash optional 8 GB and 16 GB Operating System QNX 4 25 Window manager Photon SW upgrades via network or memory card Dimensions Weight HxWxD 301x324x180 mm 11 9x12 8x7 1 inches Weight 5 9Kg 13 00 Ib for basic configuration with
7. Status Result Pass Failed GO No Halt NOGO Halt 3 5 Pressure Test Pressure bar Range bar Measured bar Accept Failed Press 1 0 5 0 4 0 6 1 1 1 0 1 2 6 Tech s Current Testing Range amp Measured amp Accept Failed Left side of HCU Tech A 3 5 5 0 Tech B 3 5 5 0 Tech C 3 5 5 0 Tech D 3 5 5 0 Right side of HCU Tech A 3 5 5 0 Tech B 3 5 5 0 Tech C 3 5 5 0 Tech D 3 5 5 0 MTRE Advanced Technologies Ltd D 3 Thermoregulation Service Manual 7 Fan s Test Accept Failed Left side HCU Visual test fan is working properly Right side HCU Visual test fan is working properly TEST SUMMARY PASS FAIL Remarks Signature Date D 4 MTRE Advanced Technologies Ltd Thermoregulation Service Manual For Stimulator MTRE Temperature Calibration Unit P N Rev Contact MTRE SERVICE S N E mail service mmi co il Hospital Tel 972 89328510 Country FAX 972 89323333 CRC Tested By 1 Water Filter Assembly Maintenance Replaced Replace water Simulator Temperature Calibration filter unit 017 00284 2 Core amp Surface Temperature Test Temp C Max Min Accept Failed Core C Surface C 42 90 43 20 42 60 37 50 37 80 37 20 36 20 36 50 35 90 33 30 33 60 33 00 27 10 27 40 26 80 22 90 23
8. Use reusable core sensors or disposable sensor adapters supplied by MTRE or YSI series 400 compatible sensors Use reusable surface sensors or disposable surface sensor adaptors supplied by MTRE only 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 Thermoregulation 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 Thermoregulation 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 Thermoregulation 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 th
9. 5 Dispose of the old filter MTRE Advanced Technologies Ltd 7 5 Hydraulic System Thermoregulation Service Manual Installing the New Filter gt To install the new filter assembly CAUTION The filter is marked with an arrow indicating the direction of water flow see Figure 7 3 and Figure 7 4 You must assemble the filter in the manner indicated 1 Connect the tubes to the new filter assembly Insert both tubes with suitable force to ensure that they are secure 2 Position the filter clamp in the chassis and tighten the filter clamp screw by hand see Figure 7 5 3 Close the rear cover and tighten the thumb captive screws by hand oW a 2 Figure 7 5 Filter Assembly Overview Table 7 2 Filter Parts Item No Qty Part No Description 1 1 200 00130 Qosina Filter Assembly 2 1 007 00334 Qosina Filter Bracket MTRE Advanced Technologies Ltd Thermoregulation Service Manual Pump The pump circulates water through the system at rates of 0 8 1 2 liters per minute The pump is a positive displacement type so it builds up pressure at the pump output This pressure is limited in two stages e Pres 1 at 0 9bar Pres 2 at 1 8 bar safety The pump is digitally controlled from the controller board and is powered by 12VDC Removing the Pump WARNING You must drain the water tank before removing the pump gt To remove the pump see Figure 7 6 1 Drain the water tan
10. CHAPTER 8 SOFTWARE Overview The software handles all system inputs and outputs It is downloaded through the RS 232 communication port to the ROM or Flash and initialized each time the system is turned on Self Test On system restart the software executes a self test The self test verifies the correct functioning of the Thermoregulation device Screen and buzzer test Flow test CRC test Cooling and heating capability test Water preheating Allon Normal operation test Note For details regarding Self Test refer to the User Manual Safety Algorithm The purpose of the Safety algorithm is to prevent device malfunction and risk to the patient by detecting one or more of a set of safety conditions and then taking one or more of the following actions Displaying a message Activating a buzzer Activating Bypass Turning off the TECs Disabling the keyboard MTRE Advanced Technologies Ltd 8 1 Software Thermoregulation Service Manual Some safety conditions are recoverable by operator action and are called Messages If the Safety algorithm detects a HALT condition it disables the Thermoregulation device by turning OFF the pump turning OFF the TECs activating the bypass and turning ON the buzzer In this condition the soft touch keys are disabled If the Safety algorithm activates the buzzer for a Message condition the operator can mute the buzzer by pressing the Alarm Mute button Halt Conditions Several con
11. Failure to do so can cause irreparable damage to the electrical components Introduction This chapter describes the electrical system of the Thermoregulation device The electrical system consists of the following elements e Power Supply Assembly on paragraph 6 4 Controller Board on paragraph 6 5 e TEC Control Thermo Electric Components Board on paragraph 6 6 Human Sensors Board on paragraph 6 7 MMI Man Machine Interface on paragraph 6 8 FP Board on paragraph 6 9 HCU Heating Cooling Unit on paragraph 6 10 Pump on paragraph 6 11 e Solenoid Bypass Valve on paragraph 6 12 Thermistors on paragraph 6 13 Float on paragraph 6 14 MTRE Advanced Technologies Ltd 6 1 Electrical System Thermoregulation Service Manual Release of PCB Spacer Supports PCB spacer support release is accomplished by means of the PCB Extraction tool see Chapter 11 Special Equipment and Tools The extraction tool enables the release of the PCB spacer supports by insertion To the hole at the end of the extraction tool where there is enough clearance see Figure 6 1 To the hole on the side of the tool where there is not enough clearance see Figure 6 2 Inserting the spacer support into the extraction tool collapses the pinch head so that the PCB can be released see Figure 6 1 and Figure 6 2 p ALUMINUM ALUMINUM Figure 6 1 Using the Extraction Tool Figure 6 2 Using the Extraction Tool from the End
12. NO GO 18 017 00236 Tool for Board Disassembly MTRE Temperature Calibration Unit P N 017 00184 The MTRE Temperature Calibration Unit tests the Human temperature sensors The MTRE Temperature Calibration Unit consists of The calibration unit One cable for verification of the Core Human sensors One cable for verification of the Surface Human sensors MTRE Temperature Calibration Unit Controls The controls are as follows e A toggle switch for Calibration or Verification e Human sensor switches a Calibration b Verification e Water Temperature switches a Calibration b Verification Cable output jack for Thermoregulation calibration Two cable jacks for calibration check of the Temperature Calibration Unit 11 2 MTRE Advanced Technologies Ltd Thermoregulation Service Manual O XX Du d CALIBRATION UNIT Meaurement AN T AR T Not In use n M chine Verslon 05 P Of 7 I P tIn use A X1 49 Y 23 Water Ternperatuse Water Temperature Sensor Calibration Sensor Verification Figure 11 1 MTRE Temperature Calibration Unit P N 017 00184 Front Panel Note The TP400 P N 017 00284 replaces the MTRE Temperature Calibration Unit P N 017 00184 see Figure 11 10 MTRE Advanced Technologies Ltd Special Equipment and Tools Thermoregulation Service Manual Analog Flow and Pressure Calibration Unit P N 017 00190 The Flow and Pressure Calibration Unit tests the pres
13. 111 2 F e Body Temperature Accuracy 0 3 C 0 4 F Temperature and Pressure Sensors e System Sensors 3 Internal Temperature Sensors Water in Water out Thermostat 9 2Pressure Detectors e Safety measures o Over pressure protection and alarm o High water temperature protection and alarm Physical Dimensions e Mobile Unit with 4 wheels and 2 brakes e 260 mm W x 625 mm D x 940 mm H 10 23 W x 24 6 D x 37 H Net Weight e 34 kg 75 Ib Electricity Input Power e 230 115 VAC with isolation transformer 50 60 Hz Maximum Current e 230 VAC 2 5A 3A e 115 VAC 4 8A 5A Environmental Operating Conditions e Temperature 5 C to 40 C 41 F to 104 F e Humidity 10 to 93 percent non condensing e Ambient temperature range of 15 C to 68 C 40 F to 158 F Environmental Storage Conditions e Humidity 10 to 93 percent non condensing e Maximum storage time without calibration is 26 weeks External Ports e 1X Isolated Serial Port LCD Display e Size 5 5 e Resolution 128x240 SOFTWARE Displayed Information e Mode of operation e Set point temperature Range 30 C 40 C e Core Temperature e Surface temperature e System status and alarms e Technician mode display Operating Modes e Mild Hypothermia Cooling o Adult Neonatal Mode e Auto Re Warming e Normothermia e Stand By e Emptying Languages German English French Finish Turkish Italian Dutch Spanish Portuguese Swed
14. 20 22 60 18 50 18 80 18 20 MTRE Advanced Technologies Lid Thermoregulation Service Manual 3 Sensors Win amp Wout Test W out C Max Temp C A A B Accept Failed B A Accepted Measured 1 0 Temp C Max Min Accept W out C W in C Failed 38 00 39 37 37 00 38 36 36 00 37 35 35 00 36 34 34 00 35 33 33 00 34 32 4 Thermostat Test Status Result Pass Failed GO No Halt NOGO Halt 3 D 6 MTRE Advanced Technologies Ltd Thermoregulation Service Manual 5 Pressure Test Pressure bar Range bar Measured bar Accept Failed Press 1 0 5 0 4 0 6 1 1 1 0 1 2 6 Tech Current Testing Range amp Measured amp Accept Failed Left side of HCU Tech A 3 5 5 0 Tech B 3 5 5 0 Tech C 3 5 5 0 Tech D 3 5 5 0 Right side of HCU Tech A 3 5 5 0 Tech B 3 5 5 0 Tech C 3 5 5 0 Tech D 3 5 5 0 MTRE Advanced Technologies Lid 7 Fan Test Thermoregulation Service Manual Accept Failed Left side HCU Visual test fan is working properly Right side HCU Visual test fan is working properly TEST SUMMARY PASS Lo FAIL Remarks Signature Date D 8 MTRE Advanced Technologies Ltd Thermoregulation Service Manual APPENDIX E DOWNLOADING UPDATED CRITICOOL SOFT
15. 4 F e Set Point Temperature 30 40 C 86 104 F Sensors accuracy e Patient Temperature 0 3 C 0 4 F Water temperature accuracy e Water Temperature 0 3 C 0 4 F Water tank Maximum Volume e 6 liters 1 6 gal Sensors 014 00020 Reusable core 014 00021 Reusable surface 014 00005 Reusable infant core 014 00028 Disposable adapter core 014 00129 Disposable adapter surface Garment size e Sizes range from 40 cm 196 cm 1 4 6 5 Wrap Duration of use e CureWrap 72 hours Quick coupling connectors e Prevent water leakage Safety mechanism e Prevents extremely high pressure and temperature Physical Dimensions e 260 mm W x 625 mm D x 940 mm H 10 23 W x 24 6 D x 37 H DGT 136 001 REV B 7 2012 1 3 Net Weight 33 kg 77 b Electricity Input power 230 115 VAC with isolation transformer 50 60 Hz Medical multiple isolation transformer 230 115 VAC Maximum Current 230 115 VAC 6 3 amp Operation Ambient Temperature 109C 409C 509F 1049F Storage and Transport Maximum storage time without calibration is 26 weeks An ambient temperature range of 40 C to 70 C 40 F to 158 F A relative humidity range of 10 to 100 n An atmospheric pressure range of 500 hPa to 1060 hPa Warranty One year Protection against electric shock Type BF Languages German English French Finish Italian Dutch Spanish Portuguese Swedish Norwegian Danish Auxiliary Systems CliniLogger
16. 6 Slide out the water tank Note To re assemble the new water tank follow the same procedure in reverse order Water Tank Top Cover Assembly The water tank top cover assembly performs the following functions Seals the top of the water tank to prevent leakage e Secures the float rod and contains the float electrical connector e Allows the flow of water to the tank by means of the by pass connector 7 4 MTRE Advanced Technologies Lid Thermoregulation Service Manual Filter Filter Clamp V Screw P A Figure 7 3 Filter Orientation Figure 7 4 Filter Assembly Replacing the Filter Filter replacement must be performed every twelve months and is performed by the hospital personnel Note An additional filter is supplied in the accessory box Removing the Filter gt To remove the filter 1 Drain the water tank see To drain the water tank Allon 2001or To drain the water tank CritiCool page 7 3 2 Remove the rear cover a Unscrew the thumb captive screws at the bottom of the cover b Pull the bottom part of the cover towards you and then down to release the lip from the chassis 3 Unscrew the filter clamp screw and remove the filter clamp see Figure 7 3 7 4 on page 7 7 4 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
17. Adaptive 1 Threshold V2mV High Sensitivity 3 Adaptive 2 Threshold 2mV High Immunity e Auto Cable Detection e Audio Indicator QRS Beep e QRS Detection Range MTRE Ltd All rights reserved Specification subject to be changed without notice Height 0 25 to 5 0 millivolt or 0 15mV Width 70 to 120 milliseconds Heart Rate Counting Range 15 to 350 BPM 15 300 Accuracy 2 BPM 300 350 Accuracy 4 BPM Note Values below 20 forced to zero Heart Rate Alarm Settings High and low rate 20 350 BPM non overlapping Leads analyzed for Heart Rate and Arrhythmia Configuration Top two displayed ECG Leads 9 I II III 3 Lead cable 9 I II III aVR aVL aVF V 5 Lead cable 9 I II III aVR aVL aVF V1 V6 12 Lead module Data Storage Beat notification RR Interval Heart Rate ST values Arrhythmia Alarms Parameter settings Cycle time and measurement time Markers Alarm event markers Respiration Leads RA LA or Leads RA LL Excitation 65 kHz 1 mA Frequency Response 0 13 to 2 5Hz Impedance Range 100 to 3000 2 Input Sensitivity Range 0 2 to 5 Q Digital Sample Rate 640 Hz Sample Resolution 24 bit Respiration Rate Counting Range 0 to 150 breaths min Less than 8 BPM is considered apnea Respiration rate Accuracy 1 per minute Respiration Alarm Settings 0 Low rate O 150 BPM 0 High rate O 150 BPM 0 Apnea User configurable 0 Cardiac coincidence alarm Data Storage 0 Respiration rat
18. C check HS board and harness PATIENT TEMP Core temperature above 38 5 C No action needed ABOVE 38 5 c 101 3 F PATIENT TEMP Core temperature bellow No action needed BELOW 35 5 C 35 5 C 95 9 F CORE READOUT Core temperature reading If message appears when actual HS TOO LOW below 30 C or 0 8C below Set core reading is adequate check Point HS board and harness CORE READOUT Core temperature reading is 2C Select operation from the menu or HS TOO LOW CHECK CORE AND OPER ATE below Set Point Target Temp fix the core temperature probe If message appears when actual core reading is adequate check HS board and harness No display Faulty controller board Replace controller board see chap ter 6 Electrical System Faulty MMI Replace MMI see chapter 6 Electri cal System Faulty controller board MMI flat cable 10 4 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Table 10 2 Text Messages Message Problem No display upon startup Possible Problem Action to be Taken Report Sec Faulty FP board Check fuse F6 on controller board FP board and MMI sharing the Replace FP board same line Replace MMI Pressure MTRE Advanced Technologies Lid 10 5 Troubleshooting Thermoregulation Service Manual 10 6 MTRE Advanced Technologies Lid CHAPTER 11 SPECIAL EQUIPMENT AND TOOLS This chapter describes the followin
19. CritiCool cover and disconnect the MTRE serial cable from CritiCool 16 Turn CritiCool ON 17 Enter Technician Mode see Appendix A Technician Mode Check that the new version is listed on the top of the screen and verify that the checksum CRC number is equal to the one in the Download Complete message MTRE Advanced Technologies Ltd Thermoregulation Service Manual Uer 5 5 16 81 13 13 45 82 5887 HUL Hhyusical I jr 2 QN He at Coo l Pump Thermobr ale Cn J i 4 k Y mj i E you Ji i Ri MAT fa Cal BARBAS pI Use right butto toggle TECs NN 0604500 TECS are MIE Figure E 5 Technician Mode Screen If the checksum CRC in the Download Complete message in Figure E 4 is equal to the value displayed at Technician Mode the software download was successful 18 Click Exit IMPORTANT Ifthe checksum CRC does not match turn the system OFF and reperform Download MTRE Advanced Technologies Ltd
20. ER ER NEUTRA T Ee DS 11 7 Standard TOO lS EE 11 8 Calibration Test for the MTRE Temperature Calibration Unit eseennenrnornernrnrenrnnnrnvrersrrsrrrnrnernnrnsense 11 8 Thermostat Verification Tool arer nennen enne nnne nnne trennen eren nnne nnns 11 9 PCB Extraction Lool si ince recette ettet reete ee t ER iE eie M ne eR e ete arra 11 9 Chapter 12 Specifications Appendix A Technician Mode Technician Mode ettet e icr heh EI He E eclesie Vela e tee esee aorta A 1 Technician Mode Cri A d RR P Et eec Rete a eee A 1 Technician Mode Screen Details esses eene eene A 2 Entering Technician Mode vc it vy dees de de eR beca A 4 Appendix B Spare Parts List Disclaimer E A dba ee e eerte Ad E tate tea d rotta B 1 CritiCool Cooling Control Unit esses enne nennen ener en tren nennen enne B 1 CritiCoolrM Spare Parts List ic Ai RR ECHO APERIRE cbs eo ee ep eee B 2 MTRE Advanced Technologies Ltd vi Thermoregulation Service Manual Allon 2001 Warming Control Unit Version 05 sss eene nennen enne B 17 Allon 2001 Spare Parts List For Version 05 rsrrrnnrrnnrnrrsnvrrnnrenernrrrsnrrsrsrersensrrnersrsssrerssrrnnennn B 17 Upgrade Package for Allon 2001 Warming Control Unit esee B 17 Appendix C Service Form Appendix D Periodic Maintenance For Stimlator TP 400 FOGG rrreessnvnvnssnsrnnssnunnenssvnnenssvnnenssvnnenssvnnnessvsnnensssn
21. 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 Thermoregulation System is designed to regulate body temperature as determined by the physician Warnings 1 The 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 2 The patient should be constantly attended by a physician 3 Mishandling of the temperature regulation equipment can be potentially harmful to the patient 4 Do not plug wet PL plugs of the human sensors into the sensor sockets of the Thermoregulation device 5 The user should verify that no fluids are present at the skin Garment interface during the operation 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 6 In operations 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 MTRE Advanced Technologies Ltd 2 1 Warnings and Precautions Thermoregulation Service Manual Thermoregulation system does not prevent this occurrence It is therefore recommended to use pressure
22. Item Number Element in Figure 5 1 Removal and re assembly MMI Cover The MMI cover provides access to the human sensors board It is attached with two M4x8 socket head Allen screws and three hexagon nuts screwed to the Human Sensor temperature sockets The MMI is connected to The main controller with a ribbon cable e A drainage tube by means of a gutter that drains any fluids spilled on the MMI The fluid flows down through the drainage tube and exits at the bottom of the unit gt To remove the MMI 1 Unscrew the two Allen head screws located behind the moving panel 2 Open the three nuts screwed on the human sensor jacks 3 Disconnect the connector of the ribbon cable from the controller board J4 and slide the ribbon cable through the chassis gt To re assemble the cover 1 Connect the connector of the ribbon cable to the controller board J4 and slide the ribbon cable through the chassis 2 Close the three hexagonal nuts and tighten with a torque of 80 90 Nem 3 Screw the two Allen head screws located behind the moving panel Caution Do not stretch the ribbon cable when removing the MMI cover MTRE Advanced Technologies Ltd Thermoregulation Service Manual Table 5 1 Thermoregulation Device Elements and Removal Instructions Element Item Number in Figure 5 1 Removal and re assembly Left Side Cover 2 Right Side 3 Cover The left side cover provide
23. Pin Female Crimp 16 AWG Solenoid Bypass Valve Refer to Section Solenoid Bypass Valve in Chapter 6 Electrical System MTRE Advanced Technologies Lid Hydraulic System Thermoregulation Service Manual Water In and Water Out Connectors gt To remove the Water out Assembly l 2 3 4 5 Remove the handle and the top cover see Chapter 5 Panels and Covers Remove the right side cover Disconnect the 6mm pressure tube Disconnect the 8mm flow tube Unscrew the two Philips screws from the water bracket Note To re assemble the new Water out assembly follow the same procedure in reverse order gt To remove the Water in Assembly 1 2 3 4 7 10 Remove the handle and the top cover see Chapter 5 Panels and Covers Remove the left side cover Disconnect the 8mm flow tube Unscrew the two Philips screws from the water bracket Note To re assemble the new Water in assembly follow the same procedure in reverse order Figure 7 8 Water in and Water out Connectors MTRE Advanced Technologies Ltd Thermoregulation Service Manual Table 7 5 Water Connectors Parts Item No Qty Part No Description 1 009 00006 Screw M4x8 Pan Philips s s 2 200 00097 Water in Female Assembly 3 200 00097 Water out Female Assembly MTRE Advanced Technologies Lid 7 11 Hydraulic System Thermoregulation Service Manual 7 12 MTRE Advanced Technologies Lid
24. Tank see Water Tank Assembly on page 7 3 Removing the Cover see Removing the Cover on page 9 20 Replacing the Water Filter see Replacing the Water Filter on page 9 2 Activating the CritiCool Machine see Activating the CritiCool Machine on page 9 2 OG INS M Ne EG Verification a Human Sensors Verification see Activating the CritiCool Machine on page 9 2 b Water Temperature Sensors see Water Temperature Sensors Verification on page 9 4 c Thermostat Verification see Thermostat Verification on page 9 6 d Pressure Verification see Pressure Verification on page 9 8 e TEC Current Test TEC Current Test on page 9 9 7 Checking for Water Leakage see Check for Water Leakage on page 9 11 8 Self test see Self test on page 9 11 MTRE Advanced Technologies Ltd 9 1 Periodic Maintenance Thermoregulation Service Manual Removing the Cover Remove the following e Handle Top cover Rear cover For instructions on panel removal see Chapter 5 Panels and Covers Replacing the Water Filter Replace the water filter Follow the instructions in Chapter 7 Hydraulic System Activating the CritiCool Machine gt To Activate the Criticool Machine Activate Technician Mode Turn on the Thermoregulation system and immediately press simultaneously the left SILENCE and right UP buttons The Main Menu screen appears Human Sensors Verification Your calibration tool kit may includ
25. drive drop down list select the C drive Double click the MTRE PC Download folder Note Make sure that the File types box displayes the MTRE_BIN bin type Select CLINIC Ver xyz BIN for example CLINIC Ver 5 4B4 BIN file and verify the file is highlighted Click OK and verify that The File Download window is displayed Open the top cover of CritiCool and turn CritiCool on In the File Download window click Start to start the download process During the download a progress indicator appears on the File Download window and a Program Burn label appears indicating the burn precentage MTRE Advanced Technologies Ltd Thermoregulation Service Manual File Download File Name CAMTRE_ PC_Download Clinic ver 3 4b4 bin HS HS00 FPR FPOO A Controller Flash Erase Success Program Burn 14 percent Figure E 3 File Download window LEDs 4 and 5 on the Control Board of CritiCool flicker during the download process At the end of the download process both LEDs should cease to flicker and remain lit IMPORTANT Should one of them turn off the download process is incomplete and you need to perform the download process again At the end of the download process the following message appears Download complete Ifthe CRC on the CritiCool technician screen is 0x5529 then press the Exit button below Download Again Exit Figure E 4 Download Complete Message 14 Turn CritiCool OFF 15 Close the
26. end 4 Connecting Tubes for ThermoWrap or CureWrap Garments Part No 200 00109 Two flexible 2 5m long connecting tubes connect the Garment with the Thermoregulation 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 Thermoregulation device end and with two female Quick Coupling Connectors at the Garments end 5 Male Connector for Draining Water Tank Part No 002 00069 Refer to Section Draining the Water Tank in Chapter 9 6 Spare Water Filter Part No 200 00130 For annual filter replacement packed in the accessory box 7 Handle Allon Model Part No 007 00333 CritiCool Model Part No 007 00365 3 6 MTRE Advanced Technologies Ltd CHAPTER 4 INSTALLATION Pre installation Requirements Space and Environmental Requirements The Thermoregulation device is supplied on a trolley as a mobile unit for user convenience Locate the Thermoregulation device not less than 5 cm 2 from other objects to avoid impairing its ventilation The following dimensions should be considered when placing the Thermoregulation device 260 mm W x 625 mm D x 940 mm H 10 23 W x 24 6 D x 37 H Electrical Requirements 230 120 VAC 500W CAUTION Verify that the voltage switch is set for the local voltage Unpacking and Inspection The Thermoregulation device has undergone full quality assurance testing before shipment and should be operational up
27. from the Side Slide Lock Connector Connectors on the PCB are equipped with a slide lock assembly The slide lock assembly consists of a sliding bracket fitted on the PCB connector and corresponding lock posts that fit into the mounting holes of the mating connector After attaching the flat cable connector to the PCB slide the bracket to lock the connectors together To release the connectors slide the bracket in the opposite direction Power Supply Assembly The Power Supply Assembly consists of the following e External electrical connection by means of a hospital grade power cable switchable 230 120 VAC with two 6 3 amp fuses 6 2 MTRE Advanced Technologies Lid Thermoregulation Service Manual On Off switch Medical isolation transformer 230 120V 500W Two current harnesses to the TEC Control board One current harness to the controller board Current ground harness gt To remove the Power Supply Assembly 1 Remove the handle and the top cover see Chapter 5 Panels and Covers 2 Remove the two Philips head screws from the ON OFF switch panel in the rear of the Thermoregulation device 3 Remove the controller board see Removal of the Controller Board paragraph 6 5 2 4 Remove the four Philips head screws and washers 5 Release all cables leading from the controller board and both halves of the TEC Control board Note To re assemble the Power Supply Assembly follow the above pr
28. from the front of the Thermoregulation device N ex e PE f t xo Figure 6 17 Solenoid Valve Removal Table 6 16 Solenoid Parts Item No Qty Part No Description 1 1 200 00078 Solenoid Valve Assembly 2 2 009 00024 Ejot Screws 35x12 Thermistors The thermistor used for water out and thermostat 1s a double thermistor unit assembly containing two thermistors in one jacket In case of damage in one of the thermistors replace the complete component The thermistor used for Water in is a single thermistor unit assembly Water out and Thermostat Thermistor Replacement gt To remove the Water out and Thermostat Thermistor 1 Drain the water tank see Chapter 7 Hydraulic System MTRE Advanced Technologies Ltd 6 23 Electrical System Thermoregulation Service Manual 2 Remove the handle and the top cover see Chapter 5 Panels and Covers 3 Open the right side cover 4 Disconnect the water out and thermostat two pin Molex connectors from the Human Sensors board see Figure 6 18 Water In Two pin Molex Socket Thermostat Two pin Mdex Socket Water Out Two pin Molex Socket Figure 6 18 Socket Location 5 Follow the cable to the other end and remove the thermistor by pressing the release ring from the water connector gt To re assemble the new water out and thermostat thermistor 1 Perform the same procedure in reverse order 2 Fill the water tank and che
29. its side on the cloth to prevent damage 1 Remove the handle and the top cover see Chapter 5 Panels and Covers 2 Open the appropriate side cover 3 Release the electric connector by unscrewing the two flat screws on top of the connector Firmly grasp the electric connector and pull up to release 4 Release the Water in tube and the Water out tube from the HCU by pressing the release ring of each fitting and pulling out the tubes 5 Remove four nuts with a 7mm socket and washers two on each side of the HCU 6 Unscrew two Philips screws on the bottom sides of the HCU Access the screws through holes in the frames of the Thermoregulation device 7 Grasp the two sides of the HCU and carefully slide it out of the Thermoregulation device 8 Place the HCU on a flat surface CAUTION The heavy heat sinks can deform the unit if it is not placed on a flat surface Note To re assemble the HCU follow the above procedure in a reverse order Note that there are oblong holes in the bracket of the HCU Before completely tightening the nuts lift the HCU Figure 6 16 HCU Removal MTRE Advanced Technologies Ltd 6 21 Electrical System Thermoregulation Service Manual Table 6 15 HCU Parts Item No Qty Part No Description 1 1 200 00054 HCU Assembly 2 2 010 00001 Spring Washer M3 s s 3 2 009 00005 Screw M3x6 Pan Philips s s 4 4 011 00001 Nuylock Nut M4 s s Blue 5 4 010 00008 Flat Washer M4 s s
30. tests the tolerance of the thermostat in the Thermoregulation device The tool has two sides both with two pin Molex connector Each side is labeled on the main wire OUTPUT Simulates Series 400 Probe TEMPERATURE nt TEMPERATURE PROBE SIMULATOR 888 TP400 Figure 11 10 Thermostat Verification Tool P N PCB Extraction Tool The PCB Extraction tool is used to release PCB spacer supports MTRE Advanced Technologies Lid Special Equipment and Tools Thermoregulation Service Manual Figure 11 11 PCB Extraction Tool 11 10 MTRE Advanced Technologies Lid Thermoregulation Service Manual Specifications CHAPTER 12 SPECIFICATIONS The following specifications are included Allon CritiCool CritiCool Pro MTRE Advanced Technologies Ltd 12 1 se A Trn r MMTRE VER INE ad z t E A Member of Mennen Medical Group es ag Thermal Regulation System Specification Servo controlled Non Invasive thermal regulation using water circulating ThermoWrap and CureWrap Garments covering up to 85 of body surface Displays Net Weight e Mode of operation e 33kg 77lb e Set point temperature e Core Temperature Electricity Input power e Surface Temperature e Alarm displays e 230 115 VAC with isolation transformer 50 60 Hz e Pump On Off icon e Medical multiple isolation transformer 230 115 VAC Default mode e Normothermia management Controller range e Water Temperature outflow 13 40 8 C 55
31. top cover see Chapter 5 Panels and Covers 2 Detach the three cables voltage in voltage out control from each side of the TEC control board 3 With the extraction tool release all four PCB spacer supports 4 Slide out the TEC control board from the side Note To re assemble the TEC control board follow the above directions in reverse order MTRE Advanced Technologies Ltd 6 11 Electrical System Thermoregulation Service Manual Figure 6 8 TEC Controller Assembly Table 6 8 TEC Controller Components Item No Qty Part No Description 1 1 300 00117 TEC Controller Assembly 2 4 004 00030 PCB Spacer Support ECC 5 Human Sensors HS Board The Human Sensors board receives input from the Human temperature sensors Water in and water out temperature sensors Thermostat sensor The Human Sensors board relays voltage back to the controller board The controller board converts the analog signal from analog to digital and makes the temperature adjustments according to the system calibration All Human Sensor inputs are from thermistor temperature sensors 6 12 MTRE Advanced Technologies Lid Thermoregulation Service Manual Table 6 9 Human Sensor Board Input Signal Sensor Input Type Measurement Core Thermistor Continuous Surface Thermistor Continuous Water in Thermistor Continuous Water out Thermistor Continuous Thermostat Thermistor ON OFF
32. used for dispersing energy heat or cold from the Thermal exchange elements Fan 6 18 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Note The HCU is an integrated unit If any of the components listed above is faulty replacement of the entire HCU is necessary Thermal Exchange Unit Z Heat Exchanger Figure 6 14 6 14 HCU Assembly Item Qty Part No Description No 1 1 200 00054 HCU Assembly Z Heat Exchanger There are four Z heat exchangers on each side of the Thermoregulation device Water flows from the water tank through the filter through the pump and through each set of the Z heat exchangers The water is either heated or cooled in the Z heat exchanger by the thermal exchange units according to the demands of the system Figure 6 15 displays the water flow represented by the geometric cross hatch MTRE Advanced Technologies Ltd 6 19 Electrical System Thermoregulation Service Manual Figure 6 15 Z Heat Exchanger Cross section Thermal Exchange Components Peltier The TEC components are solid state modules no moving parts that convert electrical energy into a temperature gradient known as the Peltier effect They are composed of two similar alloys that have different free electron densities at the same temperature One is composed of material having a deficiency of electrons while the other has an excess of electrons As current flows up and down
33. 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 temperature accuracy e Water Temperature 0 3 C 0 4 F Water tank Maximum Volume e 6 liters 1 6 gal Sensors 014 00020 Reusable core 014 00021 Reusable surface 014 00005 Reusable infant core 014 00028 Disposable adapter core 014 00129 Disposable adapter surface Garment size e Sizes range from 40 cm 196 cm 1 4 6 5 Garment Duration of use e ThermoWrap 28 hours e CureWrap 72 hours Quick coupling connectors e Prevent water leakage Safety mechanism e Prevents extremely high pressure and temperature Physical Dimensions e 260 mm W x 625 mm D x 940 mm H 10 23 W x 24 6 D x 37 H DGT 063 000 Rev B 07 2012 A4 Maximum Current e 230 115 VAC 6 3 amp Operation Ambient Temperature e 10 C 40 C 509F 1049F Storage and Transport e Maximum storage time without calibration is 26 weeks e An ambient temperature range of 40 C to 70 C 40 F to 158 F e Arelative humidity range of 10 to 100 n e An atmospheric pressure range of 500 hPa to 1060 hPa Warranty e One year Protection against electric shock e Type BF Languages German English French Finish Italian Dutch Spanish Portuguese Swedish Norwegian Auxiliary Systems e CliniLogger Regulatory CE 0473 Allon 2001 FDA Clearance K024128 EN 60601 1 EN 60601 1 2 Type BF Degree of protection against
34. 40 360 480 minutes Pressure Transducer Accuracy 3 mmHg or 2 whichever is greater Heart Rate 30 to 240 BPM Adult Pediatric 40 to 240 BPM Neonatal Data Storage Measurement time markers S D M Alarm even markers Temperature YSI400 Body temperature 0 C to 45 C 32 F to 113 F 0 1 C Temperature Alarm Range 25 C to 45 C 77 F to 113 F Range 45 Delta Temperature Delta temp Accuracy 0 1 C End Tidal CO2 Microstream EtCO2 Flow rate 50 ml min accuracy 7 5ml min 15ml min Displayed Data o Waveform labels and annotations 0 EtCO2 in CO2 and respiration rate values CO2 Display Range 0 99 mmHg Measurement Resolution Typical Accuracy 2 mmHg for CO2 range of 0 38 mmHg 0 5 for CO2 range of 39 99 mmHg 0 08 for every 1 mmHg above 38 mmHg Respiration Rate 0 Oto 70 bpm 1 bpm 0 71 to 120 bpm 2 bpm 9 121 to 150 bpm 3 bpm Rise Time 190 msec 10 90 Delay Time 2 7 Sec 10 90 typical Start up Time 30 sec typical Automatic Compensation At least once per hour Ambient Temperature 0 65 C Humidity 10 95 RH non condensing Barometric Pressure 430 795 mmHg 1250 to 15 000 ft 380 to 5200 meter Calibration required Initially after 1200 operating hours and then once a year or 4000 operating hours CO2 Alarm Limits O to 100 mmHg 0 to 10 0 to 15 kPa Respiration Rate Alarm Limits Neonatal O to 150 BMP Adult O to 50 BPM Data Storage EtCO2 inC
35. AE seas tens 6 2 Controller Board E M 6 4 Controller Board Fuses uidit edi GERE ERN ESQ IM EM EUN REGE a etis 6 7 Removal of Controller Board eene eene nennt eene enne nennen 6 7 TEC Control Thermo Electric Components Board sse eene 6 8 Human Sensors HS Board a Ede ds 6 12 MMI Man Machine Interface sese seen entrent nnne nennen nne 6 15 Jugis tri e EUM Re 6 16 HCU Heating Cooling Unit oreet t eem tttm ete ee eo E ED ER ege 6 18 Z Heat EX Chan Ger A en 6 19 Thermal Exchange Components Peltier sess 6 20 Heat Sink ien eese dro dne OR MR rt dh p ib 6 20 Fan E A 6 20 Pump 52e Ne een aeo teh het ded ae Rege ERIS EPOD e RITU EOS TRE RN 6 22 Solenoid Bypass Valve i duse atem trs Erie dos te oe leaded Leo Teu a pu ERN Pese dou 6 22 Ms NON 6 23 Water out and Thermostat Thermistor Replacement essere 6 23 Water in Thermistor Replacement ssesssssesseseeeeeeen ener enne ennt inen enint 6 24 PIO At tenta seen 6 25 Chapter 7 Hydraulic System Introduction 11 et enit litis edt tib T al TER I edt ia 7 1 Water Tank Assembly ricino i ERAI Eonia IER eee oce eI SIUE 7 3 Water Tank Top Cover Assembly sees eee ener erre nnne entere 7 4 Piller vas 7 5 LEE 7 5 Replacing the Filter czas ei denna 7 5 Removing the Filter 5 5m onn neieo e
36. Cool Spare Parts List Note When Ordering Boards For Exchange EX Fill Up a Service Call Form and return to the Factory the Faulty Board within 30 Days Part Number Description Controller board 300 00118 300 00118EX Exchange of Controller board 300 00117 TEC control board 300 00117EX Exchange of TEC control board B 2 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Human sensor board 300 00016 Controller board TEC control board harnessx2 300 00098 300 00102 Controller board human sensor board harness 300 00100 MTRE Advanced Technologies Lid B 3 Thermoregulation Service Manual Part Number Description Controller board flow amp pressure board harness 300 00099 Controller board RS 232 connector harness 300 00101 Main harness right side 300 00050 Main harness left side 300 00051 B 4 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Level sensor harness 300 00091 Controller board pump harness 300 00080 Top panel assembly display amp cover 200 00140 MTRE Advanced Technologies Ltd B 5 Thermoregulation Service Manual Part Number Description Water filter assembly 200 00130 Pump assembly 200 00115 S
37. I It has two identical halves that operate independently Both halves of the TEC Control board receive power supply directly from the transformer rectify it and distribute power to the TECs via digitally controlled current switches The internal system algorithm on the controller board calculates the human and temperature sensors values and determines the quantity of TEC pairs actuated by the TEC control boards Digital signals from the main control board are processed by the local MSP controller on the TEC control board The MSP controller controls pairs of P and N MOSFET transistors that drive the TEC units Each 6 8 MTRE Advanced Technologies Lid Thermoregulation Service Manual pair of transistors can depending on the command drive the TEC unit in forward or reverse current to heat or cool the water MSP controller also measure the output voltage of each power bridg and provide status indication by dedicated color Reg Green or orange Table 6 5 TEC Control Board Fuse List Identifier Value Size Type Voltage to F3 25A 6 3mmx32mm Slow Blow D8 F4 25A 6 3mmx32mm Slow Blow D9 FIL 25A 6 3mmx32mm Slow Blow D6L F2L 25A 6 3mmx32mm Slow Blow D5L Table 6 6 TEC Control Board Connectors Identifier Type Description J3 Header 16 Control signals from controller board J4L Header 16 Control signals from controller board J1 Header 8 Powe
38. If all the TECs are within tolerance replace the TEC control board 7 Turn the device OFF 8 Repeat the entire procedure for connector J21 on the other side of the TEC control board Check for Water Leakage Dry the area around the Thermoregulation device While running the system at high pressure check all tubes for water leakage Return all covers Self test At the completion of the routine maintenance procedure activate the Thermoregulation device and run a complete self test Replacing Controller Board Fuses To replace a blown fuse on the controller board it is not necessary to remove the board from the chassis Replacement fuses refer to Table 6 5 TEC Control Board Fuse List on page 6 9 in MTRE Advanced Technologies Ltd 9 11 Periodic Maintenance Thermoregulation Service Manual Chapter 6 Electrical System can be soldered to the print side of the controller board to the specific fuse contact point gt To replace a blown fuse on the controller board iP 2 3 4 9 12 Remove the handle Open the top cover Locate the blown fuse Solder the replacement fuse to the proper contact point contact points are shown in Figure 9 5 Return the top cover and handle Figure 9 5 Controller Board Fuse Location MTRE Advanced Technologies Ltd CHAPTER 10 TROUBLESHOOTING WARNING The repair calibration and servicing of the Thermoregulation System should be performed only by MTRE Adv
39. O2 and Respiration Rate values Alarms Apnea Alarm Exhaust Gas Outlet Languages English Dutch French Italian Spanish Espanol Portuguese Turkish Russian Polish Regulatory Approvals EN 60601 1 EN 60601 1 1 EN 60601 1 2 Degree of protection against electrical shock ECG RSP IBP CO and TEMP Type CF NIBP SpO2 and EtCO2 Type BF CE Mark 0473 FDA Clearance K073140 MTRE Ltd All rights reserved Specification subject to be changed without notice Specifications Thermoregulation Service Manual 12 6 MTRE Advanced Technologies Lid APPENDIX A TECHNICIAN MODE Technician Mode Verification and calibration tests are done while the Thermoregulation device is in Technician mode This mode displays the readings of the verification and calibration tests as well as additional information as to the status of the Thermoregulation device and error codes that are necessary in the analysis and correction of failure Following is a detailed description of these functions Technician Mode Screen 5 16 1 13 13 45 02 5887 ade Ph sical eat Point ireTmP F F Pod l Fumi Thermor at AAAAAS SS Use ri ght T la TR AL toggle TECE 644800 TECS i Figure A 1 Technician Mode Screen MTRE Advanced Technologies Ltd A 1 Thermoregulation Service Manual Technician Mode Screen Details 1 Software Version Number 2 Date and Time dd mm yy hh mm ss 3 Functions The following functions ar
40. SURF Sensor YSI B C GREEN 014 00021 1 Accessories Box 015 00035 1 ThermoWrap Connecting Tube 200 00109 1 Filter Assembly 200 00130 1 Quick Reference Guide English 014 00058 1 Label Set Multilanguage 200 00091 Table 4 2 Acc Kit for Adult with Interface Cables Only for Disposable Sensors 200 00410 QTY Description Part Number 1 Connector 1 4 with hose barb 002 00069 1 Interface Cable for Disp Core Sensor 014 00028 1 Interface Cable for Disp SURF Sensor 014 00029 1 Accessories Box 015 00035 1 ThermoWrap Connecting Tube 200 00109 1 Filter Assy 200 00130 1 Quick Reference Guide English 014 00058 1 Label Set Multilanguage 200 00091 MTRE Advanced Technologies Ltd Installation Thermoregulation Service Manual Table 4 3 Acc Kit for Infant with Reusable Temperature Sensors 200 00420 QTY Description Part Number 1 Connector 1 4 with hose barb 002 00069 1 Infant Eso Rectal Core Sensor 014 00005 1 SURF Sensor YSI B C GREEN 014 00021 1 Accessories Box 015 00035 1 ThermoWrap Connecting Tube 200 00109 1 Filter Assy 200 00130 1 Quick Reference Guide English 014 00058 1 Label Set Multilanguage 200 00091 CritiCool Accessory Kits Table 4 4 Acc Kit for Adult with Reusable Temperature Sensors 200 00300 QTY Description Part Number 1 Connector 1 4 with hose barb 002 00069 1 Adult Eso Rectal Core Se
41. Technician Mode Screen in Appendix A Technician Mode present in the system The errors messages in technician mode are read from right to left in order of severity Each character in the error message is a hexadecimal number and represents a group of errors see Table 8 2 To view the error messages enter Technician mode see Appendix A Technician Mode Explanation of Error Messages In the following example the third number from the right C represents Error Group 3 errors 9 12 When translated into binary code see Table 8 3 it yields a four digit number read from right to left Each 1 in conversion to binary represents an activation of an error message Table 8 2 Error Messages Error Group Description Error Number 00000001 Core readout too low 1 00000002 HALT SetPoint 00000004 Patient temperature less then 35 5 C 95 9 F 00000008 Patient temperature high then 38 500C 101 3 F 00000010 Water out temperature is less than 10 000C 50 F 2 00000020 Water out temperature is higher than 42 000C 107 6 F 00000040 Water level in water tank is too low 00000080 Internal pressure pressure too low or too high 00000100 Available for future use 3 00000200 Check ThermoWrap pressure is higher then 0 8 bar 00000400 Connect core sensor to the Thermoregulation device 00000800 Wrong core sensor is inserted to the Thermoregulation device socket 00001000 Conn
42. Thermoregulation Systems S E RW LGeE M A N U A L Revised December 2013 AAMTRE 7 7 VI For CritiCool machines with CE 0473 Conformity according to the Council Directive 93 42 EEC concerning Medical Devices as amended by 2007 47 EC Manufacturer s Name ud MTRE Advanced Technologies 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 US Representative Mennen Medical Corp 290 Andrews Road Feasterville Trevose PA 19053 3480 Phone 215 259 1020 Fax 215 357 2010 Catalog No FDT 200 000 Rev C Revised December 2013 For 100 OPT99 Copyright MTRE Advanced Technologies Ltd 2013 All RIGHTS RESERVED Registered trademarks are the intellectual property of their respective holders Thermoregulation Service Manual Copyright 2013 by MTRE 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 U S Patent No 6 500 200 BI Disclaimer MTRE is not responsible for any consequential or incidental damages or expenses of any kind impairment of or damage to other goods or to
43. WARE gt To download updated CritiCool software to your PC 1 Turn on the PC 2 Double click My Computer 3 In drive C create new folder and name it MTRE PC Download 4 Copy the Pc Download exe file from the CD or e Mail to the MTRE PC Download folder 5 Copy the CLINIC Ver xyz BIN file CLINIC Ver 5 4B4 BIN in the current version from the CD or e Mail the to the MTRE PC Download folder gt To download and install the update on CritiCool 1 Turn on the PC 2 Verify that the MTRE serial cable is connected between the PC and CritiCool 3 Browse to the MTRE PC Download folder and double click the Pe_Download exe file to open the installation program 4 DNE PC Download bid COM Port Com I Speed f 9200 Board Type 8 Figure E 1 MTRE PC Download Window 4 From the COM Port drop down list select the number of the COM port you connected to the serial plug on your PC MTRE Advanced Technologies Ltd E 1 E 2 10 11 12 13 Thermoregulation Service Manual From the Speed drop down list select 19200 From the Board Type drop down list select the board type Boards 300 00118 are type 6 the other are type 5 Press NEXT to continue The Select File window is displayed Select file Cunert dive lt D hd Current directory D Project Ver 5 4b4 Up one directory fa Clinic ver 5 4b4 bin MTRE BIN bin Figure E 2 Select File Window From the Current
44. al assist request Please send the form to neomi Q mmi co il Thermoregulation Service Manual APPENDIX D PERIODIC MAINTENANCE for CritiCool Pro and Allon P N 200 00136 063 Period maintenance description is divided into two parts according to the type of simulator used For Stimlator TP 400 FOGG e For Stimulator MTRE Temperature Calibration Unit For Stimlator TP 400 FOGG P N Rev Contact MTRE SERVICE S N E mail service mmi co il Hospital Tel 972 89328510 Country FAX 972 89323333 CRC Tested By 1 Water Filter Assembly Maintenance Replaced Replace water Simulator TP 400 FOGG Temperature filter Calibration unit 017 00284 2 Core amp Surface Temperature Test Temp C Max Min Surface C Core C Accept Failed 20 20 30 19 70 25 25 30 24 70 30 30 30 29 70 35 35 30 34 70 36 36 30 35 70 38 38 30 37 70 40 40 30 39 70 MTRE Advanced Technologies Ltd D 1 3 Sensors Win amp Wout Test Thermoregulation Service Manual Max Temp C W out C A A B Accept Failed A B Measured Accepted 1 0 Temp C Max Min Surface Core C Accept Failed Temp C C 38 39 37 37 38 36 36 37 35 35 36 34 34 35 33 33 34 32 D 2 MTRE Advanced Technologies Ltd Thermoregulation Service Manual 4 Thermostat Test
45. anced Technology Ltd or authorized agents of MTRE Advanced Technology Ltd Halt Messages Halt messgaes provide information in cases of problems that cause the system to shutdown Note The Report Section columns in Table 10 1 indicate the relevant sections for reporting the action item in the Maintenance Verification Calibration or Service Reports Table 10 1 Halt messages System Shutdown Message Possible Problem Action to be taken Report Sec No power Power switch OFF Turn power switch to ON position Power cord connected insecurely Secure power cord No Power in wall connector Use another wall connector Main Fuses 6 3A blown Replace faulty fuses Faulty AV voltage from trans Replace transformer assembly Service report former secondary Halt 1 or 4 System detected a flow problem Replace the filter Check FP harness connector Pressure Check Replace the pump Pressure Check replace FP board Pressure Replace controller board Complete MTRE Advanced Technologies Lid 10 1 Troubleshooting Thermoregulation Service Manual Table 10 1 Halt messages System Shutdown Message Possible Problem Action to be taken Report Sec Halt 3 System detected thermostat Check hardware thermostat with cali Thermostat or HS tripped indicating a likely over bration verification tool If failed the heatin
46. 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 Thermoregulation System or components thereof f The power supplied to the System or any part thereof differs from the rated value or any external device attached by user creates conditions 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 shou
47. ated to the right of the RS 232 cable when facing the right side of the Thermoregulation device refer to the Controller Board Component Placement figure in Chapter 6 Electrical System 7 Gradually close the valve and raise the pressure to 1 1 bar Record the value for 1 1 bar that appears on the display for Pres Pressure in the Physical column in the Verification form 8 At the end of the test open the valve Note When performing this test on a CritiCool with Neonatal configuration use a simulate core temperature use Core temperature simulators P N 017 00184 017 00284 9 8 MTRE Advanced Technologies Lid Thermoregulation Service Manual Figure 9 3 FP Pressure Gauge Table 9 4 Verification Form Pressure Pressure Verification Pressure Setup bar Range bar Result bar 0 5 0 40 0 60 1 1 1 0 1 2 You have completed the Pressure verification tests Summarize the verification results and check to see that they are within the tolerances listed in the Verification form Note If either Pressure is out of tolerance you must replace the FP board If the verification tests passed proceed to TEC Current Test on paragraph 9 12 TEC Current Test The TEC Current Test checks the current sent to each TEC from the TEC control board Both sides of the TEC control board must be checked The Tec Current Test is executed with both the TEC Current Verification Unit Figure 9 4 an
48. ater Tank Main Assy 8 1 002 00027 Quick Connector Elbow 8mm Tube 9 1 200 00130 Qosina Filter Assy 10 1 200 00115 RD5 Pump Assy 11 1 200 00069 Buffer Tube Assy MTRE Advanced Technologies Ltd Thermoregulation Service Manual Table 7 1 Hydraulic Block Diagram Elements Item No Qty Part No Description 12 1 200 00054 HCU Right 13 1 200 00054 HCU Left 14 2 002 00007 Quick Connector Straight 6mm 15 1 002 00178 Fitting Quick Reducer 10 8 16 1 002 00179 Quick Connector T 10 8 17 1 200 00131 Double Sensor Thermistor 18 1 003 00001 Solenoid Valve 3 2 Orif 3 5mm 19 1 003 00012 Solenoid Plug 20 1 300 00015 FP Assy Water Tank Assembly The water tank assembly consists of the following parts Before removing the water tank you need to drain it Water tank made of ABS It contains up to 6 2 liters of water Water tank top cover assembly made of ABS The water tank holds the float water level sensors tube connectors and float electrical connector Cap made of molded plastic Lower water connectors Water in And water out Bracket Water level indicator gt To drain the water tank Allon 2001 Connect one male connector of the connecting tubes to the water outlet under the Core socket Turn the Thermoregulation device ON l 2 3 Switch to Operation mode 4 Connect the special male connector Model No 002 00069 to the female connector of the tub
49. battery Power requirement e 100 120 VAC 2A 50 60 Hz e 230 240 VAC 1A 50 Hz Battery e Battery power Basic Lithium Ion 14 8V 5 2A Work on battery time 3 hours Charge time 3 hours e Battery power extended Lithium Ion 14 8V 10 4A Work on battery time 6 hours Charge time 6 hours Environmental Operating Conditions e Temperature 5 C to 40 C 41 F to 104 F e Humidity 10 to 93 percent non condensing Environmental Storage Conditions e Temperature 15C to 68C 59F to 154 F e Humidity 10 to 93 percent non condensing Network LAN Physical IEEE 802 3 Ethernet interface 10 100 BaseT e Protocol TCP IP e Serial Interface RS232 optional e Connectivity to Ensemble CNS Enguard Enscribe recorder and network printer e Wireless LAN optional include 9 Utilizes an industry standard 802 11b g IEEE compliant radio card 9 Dual diversity dipole antenna 0 Signal strength indicator WPA security and encryption Display e NEC 12 1 XGA 1024x768 LCD e Interface to a Remote Display e Very Big Numbers mode 0 One or Two Lead ECG WF 34 mm height HR DGT 136 001 Rev B 7 2012 Page 2 3 ritiCool Pro Monitors p cification 0 Three vital signs areas with 8 mm Waveform and 25 mm height numeric Vital Signs User Controls 5 Fixed keys Quicknob Remote Control Keypad optional Touch Screen ELO IT optional Keyboard and mouse Patient Data storage e Demographic info e Chart
50. ced Technologies Lid Thermoregulation Service Manual Pressurstat Sensor Indicated in the Technician Mode screen as Press 1 Pressurstat Sensor Indicated in the Technician Mode screen as Press 1 Figure 6 12 FP Board gt To remove the FP board See Figure 6 13 Remove the rear cover see Chapter 5 Panels and Covers 2 Detach the ribbon cable by pressing the slide lock bracket 3 With the extraction tool release all four PCB spacer supports two on each side of the board 4 Detach the two tubes connected to the piezoelectric transducers by pressing the release ring of each fitting and pulling out the tubes Note To re assemble the FP board follow the above directions in reverse order Note Label the tubes before you remove the FP board MTRE Advanced Technologies Lid 6 17 Electrical System Thermoregulation Service Manual rn HAN n re 4 f nm e i t Figure 6 13 FP Board Assembly Table 6 14 FP Board Parts Item No Qty Part No Description 1 1 300 00015 FP Board 2 4 004 00031 PCB Spacer Support LCC 10 HCU Heating Cooling Unit The HCU is the element that exchanges energy with the water as it flows through the system It is comprised of the following components e Zheat exchanger used for dispersing energy heat from the Thermal Exchange Components to the water e Thermal Exchange Components Peltier e Heat sink
51. ck for water leakage 3 Replace the right side cover Water in Thermistor Replacement gt To remove the Water in Thermistor 1 Drain the water tank see Chapter 7 Hydraulic System 2 Remove the handle and the top cover see Chapter 5 Panels and Covers 3 Open the left side cover 4 Disconnect the Water in pin Molex connectors from the Human Sensors board see Figure 6 18 5 Follow the cable to the other end and remove the thermistor by pressing the release ring from the water connector gt To re assemble the new thermistor 1 Perform the same procedure in reverse order 2 Fill the water tank and check for water leakage 6 24 MTRE Advanced Technologies Lid Thermoregulation Service Manual 3 Replace the left side cover Float The float contains a bottom switch that monitors the presence of water in the tank The non activation of the switches sends a signal to the controller board The system notifies the user with the following message Allon 1 During selftest ADD WATER 2 In other cases ATTENTION NO WATER PLEASE ADD WATER CritiCool 1 During selftest TANK IS EMPTY 2 In other cases ADD WATER Figure 6 19 Floats Electrical Connections MTRE Advanced Technologies Ltd 6 25 Electrical System Thermoregulation Service Manual 6 26 MTRE Advanced Technologies Lid CHAPTER 7 HYDRAULIC SYSTEM WARNING The repair calibration and servicing of the Thermor
52. d with the MTRE Temperature Calibration Unit MTRE Advanced Technologies Ltd 9 9 Periodic Maintenance Thermoregulation Service Manual Cable from HCU Connects Here O ENIA JI VA f RN nat N Y LA Tec CURRENT 1 2 JA N N gms NON A UN JJ mr NS T EBT UNIT MN Y Test Leads Here To Connector J1 J2L Figure 9 4 MTRE TEC Current Verification Unit WARNING Turn the Thermoregulation device OFF before connecting cables to the TEC control board Failure to do so can cause severe shock gt To check the TEC current 9 10 1 2 3 10 11 Turn the device OFF Remove the top cover Detach the cable leading from connector J1 on the TEC control board to the HCU refer to the TEC Control Board Figure 6 6 in Chapter 6 Electrical System Insert the plug of the cable leading from the HCU detached from the TEC control board in Step 3 to the TEC Current Verification Unit cable with the connector female Insert the plug of the TEC Current Verification Unit cable to connector J1 on the TEC control board Turn the device ON and enter Operation mode Connect the Human sensors calibration cable to the Core sensor socket on the Thermoregulation device and to the Output socket on the MTRE Temperature Calibration Unit Toggle the Calibration Verification switch to Verification Set the Human Sensor Verificati
53. d taque re d e dete ee 3 3 Rear Panel 2 ins M Lx E PH 3 4 JNCCOSSOFIGS 13 dnt ed trece AS dni tute ted o v THE FRE RED e E RS Eas 3 4 Chapter 4 Installation Pre mstallatiori Requirements ais 4 1 Space and Environmental Requirements esses ennt eene nnn n 4 1 Electrical Requirements 25 5 DA de ne Tags 4 1 Unpacking and Inspections nce eer Re Sas loka meet Debe rcr Re a e ie lee eg 4 Assembling the Handle 4 3 0 sio RORIS NIIT INTO BERET D ede Fee ERR E eh Ets 4 1 ACCESOS aida 4 3 Moving the Unit a tavit e de eds 4 5 Pr paration sussebass mete een egnet aaret 4 5 Locking and Unlocking the Trolley Wheels rmrsnrrnrvrnnrrerrrenrrnrrrnnvrsrrrrnrrrrrrnnernnesnnsrnnsrsrsrnnssnsesnneennesne 4 6 Storage Conditions and Transport ccccccsccssscesseessesseceseceseeeeeeesecsaecsaensecseeeeseeesecesecnseeeneeesecsaeeneseaeensees 4 6 Storage Environment ette A A eot shade eve AU A RED TRE d 4 6 Chapter 5 Panels and Covers Introduction iiid E dap peint beet de tu ire I e ERR 5 1 Removal of the Trolley etes teet atte 5 8 MTRE Advanced Technologies Ltd iv Thermoregulation Service Manual Chapter 6 Electrical System Intfoduetion ci Ad oa 6 1 Release of PCB Spacer SUPPOMS cireres rre e ter ever e dtu eli 6 2 Shde Eock Connector 5 tees iter betonen redet nee A ee e de eio td ibid 6 2 Power Supply Assembly 5 8 2 0 S ere etre
54. ditions require you to disable the Thermoregulation device to prevent possible hazard to the patient or to the operator These conditions are called HALT CONDITIONS and are listed in Table 8 1 Table 8 1 Halt Conditions Message Possible problem No power Power switch OFF Power cord connected insecurely Power in wall connector Main Fuses 6 3A blown Faulty AV voltage from transformer secondary Halt 1 or 4 System detected a flow problem HALT 2 Set point error Test of the memory Halt occurs when current Set point is not equal to the Set point previously saved to memory memory corruption Halt 3 System detected thermostat tripped indicating a likely overheating condition Halt 5 System indicating a likely program memory Halt 6 or 7 Self test detected a problem with Heating Cooling unit Halt 8 Self test detected no reading in Water in sensor Halt 13 System detected overpressure Halt 17 CritiCool only Battery is bad Halt 18 CritiCool only Software error patient not Adult and not Neonatal Halt 19 CritiCool only System shut down When we get command Shut down from Monitor End case MTRE Advanced Technologies Ltd Thermoregulation Service Manual Technician Mode Error Messages An error message displayed in Operation mode is a single error of the highest severity The message displayed in Technician mode is a coded error that simultaneously provides all the errors see Section
55. e 9 Respiration rate Alarms 0 Apnea alarms 9 Alarm event markers Invasive Blood Pressure Site Labels BPx ART PAP CVP RAP LAP ICP Input Sensitivity 5 uVolt Volt mmHg Dynamic Range 0 Pressure range 50 to 350 mmHg 0 Zero range 150 mmHg 0 Total dynamic range 200 to 450 mmHg Transducer Excitation Voltage 5 VDC Separate excitation driver for each channel Zero Accuracy 0 2 mmHg Zero Drift Less than 0 2 mmHg in 24 hours at constant temperature Blood Pressure Accuracy 2 mmHg or 2 whichever is greater exclusive of transducer Blood Pressure Linearity within 1 across entire range Waveform Frequency Response 0 40 Hz Sampling Rate 640 Hz Sample Resolution 24 bit Fault Detection Transducer in out Cable out Data Storage Systolic Diastolic and Mean Alarms Pulse Oximetry Sp02 Nellcor Oximax or Masimo SET Technology Plethysmograph waveform Saturation Range 1 to 100 Sp02 Extreme Alarm Capability Sp02 Accuracy SpO2 1 standard deviation Pulse Rate Range 20 to 250 BPM 3 BPM Saturation alarm limits 0 to 100 Data Storage Heart rate and O2 saturation Alarms Integrated Thermo Dilution Cardiac Output Adapter and Compatibility Cables CO Set interface cable 0 Ice Bath YSI 400 cardiac output interface cable 0 Dual temperature interface cable YSI 400 Temperature Range 9 Blood temperature 27 C to 45 C 81 F to 113 F 9 Injectate temperature 0 C to 25 C 32 F t
56. e GO side the resistance should be 1100 On the NO GO side the resistant should be 1020 A 2 Ifthe Thermostat Verification Tool is OK replace the Human Sensors board see Chapter 6 Electrical System and start the test again Mr E ao 04700229 Figure 9 2 Thermostat Verification Tool MTRE Advanced Technologies Ltd 9 7 Periodic Maintenance Thermoregulation Service Manual Pressure Verification Perform the pressure verification test with the Analog Flow and Pressure Calibration Unit or the Digital Pressure Calibration Unit Assembly gt To perform pressure verification 1 Remove the handle and the top cover see Chapter 5 Panels and Covers 2 Open the valve before connecting the tubes 3 Connect the connecting tubes from the Pressure Calibration Unit to the Thermoregulation device 4 Enter Technician Mode refer to Appendix A Technician Mode 5 Slowly close the valve until the pressure on the pressure gauge registers at 0 5 bar Record the value for 0 5 bar that appears on the Technician Mode display for Pres1 water out pressure in the Physical column in the Verification form See Appendix C Service Form for sample Note Do not close the tap too quickly This will lead to improper measurement of the pressure due to the reaction time of the system Perform this test fast after disconnecting connector J3 6 Remove the cable connected to connector J3 FUNK 2 on the Controller board loc
57. e Thermoregulation device The other end is attached with adhesives to the patient s skin e Disposable Surface Sensor Adapter Part No 014 00129 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 Thermoregulation device The sensor is attached with adhesives to the patient s skin and measures surface body temperature Table 3 1 Sensors and Data Provider Input Specification Model No Name Description Accuracy Resolution Type 014 00020 Core Inner body t 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 Infant Inner 0 3 C 0 1 C Medical Grade body temp Thermistor MTRE Advanced Technologies Ltd 3 5 System Description Thermoregulation Service Manual 2 Detachable Electric Power Cable and Plug Power cord European Standard Part No 014 00017 Power Cord USA Standard Hospital Grade Part No 014 00016 3 Connecting Tubes for CureWrap Part No 200 00147 Two flexible 2 5 m long color coded connecting tubes connect a CureWrap with the Thermoregulation 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 Thermoregulation device end and with three female Quick Coupling Connectors at the CureWrap
58. e Measuring Device 017 00290 Image not available B 16 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Allon 2001 Warming Control Unit Version 05 e Maintains Normothermia of 36 5 C 37 5 C e Controls Induced Hypothermia and Provides Precise Rewarming e Physician Presets Targeted Patient Temperature e Real Time Dynamic Feedback Loop e Proprietary Temperature Management Algorithms e Supports a Wide Range of Preoperative Procedures e Single Piece Design of ThermoWrap with Three Dimensional Coverage e Maximum Available Patient Surface Coverage e Pressure relief algorithm e Latex Free ThermoWrap e Includes Control Unit ThermoWrap Connecting Tubes Spare Water Filter Core amp Surface Temperature Sensors Drain Water Tank Connector User Manual Allon 2001 Spare Parts List For Version 05 Note When Ordering Boards for Exchange EX fill fp a Service Call Form and return to the Factory the Faulty Board within 30 Days Upgrade Package for Allon 2001 Warming Control Unit Upgrade Kit for Allon Version 04 Units to Allon Version 05 Table B 1 Upgrade Kit for Allon Version 04 Units to Allon Version 05 Part Number Description 200 00002 Upgrade V4 to Allon 2001 Ver 05 Warming Control Unit 230V 200 00001 Upgrade V4 to Allon 2001 Ver 05 Warming Control Unit 115V MTRE Advanced Technologies Ltd B 17 Thermoregulation Service Manual
59. e RED plug Connect the SILVER plug of the cable to the Surface sensor socket on the Thermoregulation device Turn the Human Sensor Verification knob counter clockwise to the number 42 9 Record the value that appears on the display for Surface in the Physical column in the Verification form See Table 9 1 for sample Repeat the procedure for all the remaining increments When all the increments have been recorded Human Sensor verification is complete Remove the Surface sensor calibration cable Table 9 1 Verification Form Human Sensors using MTRE Temperature Calibration Unit 017 00184 Temp C Max Min Surface C Core C Accept Failed 42 90 43 10 42 70 37 50 37 70 37 30 36 20 36 40 36 00 33 30 33 50 33 10 27 10 27 30 26 90 22 90 23 10 22 70 18 50 18 70 18 30 You have completed the Human Sensors verification procedure Summarize the verification results and check to see that they are within the tolerance MTRE Advanced Technologies Ltd 9 3 Periodic Maintenance Thermoregulation Service Manual If either of the sensors is out of tolerance refer to CHAPTER 10 Troubleshooting for the solution to this problem gt To test the proper functioning of the Human Sensors board using TP 400 FOGG Tempera ture Calibration unit P N 017 00284 1 Turn the machine ON 2 Core measurement connect Core cable between temperature simulators to the tested sensor socket
60. e either MTRE Temperature Calibration Unit P N 017 00184 or TP 400 FOGG Temperature Calibration unit P N 017 00284 The verification procedure depends on the type of your calibration device gt To test the proper functioning of the Human Sensors board using MTRE Temperature Cal ibration Unit P N 017 00184 1 Enter Technician mode 2 Connect the Core sensors calibration cable to the Output socket in the MTRE Temperature Calibration Unit Use the RED plug 3 Connect the BLACK plug of the cable to the Core sensor socket on the Thermoregulation device Note The plugs on both sides of the cable are not identical Be sure to connect the proper plug into the correct socket 9 2 MTRE Advanced Technologies Ltd Thermoregulation Service Manual 10 11 12 13 Toggle the Calibration Verification switch to Verification 017 00184 Turn the Human Sensor Verification knob counter clockwise to the number 42 9 017 00184 Record the value that appears on the display for Core in the Physical column in the Verification form Turn the Human Sensor Verification knob clockwise to the next increment 37 5 and record the new value that appears on the display Repeat the procedure for all the remaining increments according to 8 At the end of verification remove the cable from the Core sensor socket Connect the Surface sensor calibration cable to the Output socket in the MTRE Temperature Calibration Unit Use th
61. e listed in the Technician Mode screen Core sensor Core Surface sensor Surf Water in sensor Win Water out sensor Wout Pressure Pres1 Internal pressure Pres2 The Physical and ADC columns next to each function list the readings when performing the verification and calibration see Chapter 9 Periodic Maintenance The following values 1 and 2 are displayed in the Physical column for Core and Surface and they denote that the sensor is not connected that the wrong sensor has been inserted into the socket Table A 1 Physical Values Core Sensor Surface Sensor 1 Denotes that the sen Denotes that the sensor is sor is not connected not connected 2 Denotes that the Denoted that the sensor is wrong sensor has connected incorrectly in its been inserted into the socket socket 4 Error For a detailed error list and explanation see Chapter 8 Software 5 Time value listed is in tenths of a minute 6 CRC Software confirmation number indicating successful download A 2 MTRE Advanced Technologies Ltd Thermoregulation Service Manual 7 BAT Good Indication of RAM battery condition 8 SetPoint Indicates the set point temperature 9 DesireTmp Indicates the desired water out temperature 10 TECs The number on the left side indicates how many TECs are working at the present time For example 0 4 no TECs are working 1 4 one pair of TECs
62. e that is connected under the Core socket see Figure 7 2 CA Allow the excess water to drain into a receptacle pail or sink 6 When the water finishes draining turn the Thermoregulation device OFF MTRE Advanced Technologies Ltd 7 3 Hydraulic System Thermoregulation Service Manual gt To drain the water tank CritiCool 1 Turn the Thermoregulation device ON 2 Select Empty Mode 3 Connect one male connector of the connecting tubes to the water outlet under the Core socket 4 Connect the special male connector Model No 002 00069 to the female connector of the tube that is connected under the Core socket see Figure 7 2 5 Allow the excess water to drain into a receptacle pail or sink 6 When the water finishes draining turn the Thermoregulation device OFF ZELL ES Special Male mm amp Connector for Draining Mater TanH 7 Figure 7 2 Connecting Tubes and Special Male Connector gt To remove the Water Tank 1 Drain the water tank see procedure above 2 Remove the two side covers and the lower front cover see Chapter 5 Panels and Covers 3 Disconnect the two bottom tubes Water out on the right side and Water in on the left side 4 Open two self locking 7 mm nuts and washers one on each side of the tank 5 Partially slide the water tank out and from the top of the tank disconnect the float electrical connector and the water bypass tube coming from the solenoid
63. ect surface sensor to the Thermoregulation device 4 00002000 Wrong surface sensor is inserted to the Thermoregulation device socket 00004000 Available for future use 00008000 Available for future use MTRE Advanced Technologies Ltd 8 3 Software Thermoregulation Service Manual Table 8 2 Error Messages Error Group Description Error Number 00010000 Set point temperature is out of NormoThermia range 5 00020000 HALT Overpressure 00040000 HALT Thermostat 00080000 General electromagnetic interference in the sensor signal reading 00100000 Electromagnetic interference in the core sensor signal reading 6 00200000 Available for future use 00400000 Electromagnetic interference in the surface sensor signal reading 00800000 Electromagnetic interference in the water in sensor signal reading 01000000 Electromagnetic interference in the water out sensor signal reading 7 02000000 Core less than 30 C 04000000 Difference between SetPoint and Core more then 2C 08000000 Difference between SetPoint and Core more then 0 8C 10000000 Available for future use 8 20000000 Available for future use 40000000 Available for future use 80000000 Available for future use Group 8 Group 7 Group6 Group5 Group4 Group3 Group2 Group 1 0 0 0 0 2 C 0 1 Error Number 8 4 2 1 Hexadecimal 1 1 0 0 Table 8 3 Hexadecimal to Bina
64. ector female is fitted to the cable leading from the HCU yes unit Sb TEST UNIT Figure 11 7 TEC Current Verification Unit 11 6 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Calibration Cables The cables needed for verification tests and calibration checks are shown below Core Calibration Cable Figure 11 8 Core Calibration Cable Surface Calibration Cable Figure 11 9 Surface Calibration Cable MTRE Advanced Technologies Ltd 11 7 Special Equipment and Tools Thermoregulation Service Manual Standard Tools Crescent wrenches 3 4 9 16 13 16 Large long nosed pliers e Small long nosed pliers Scissors e Retractable utility knife Cutters Set of Allen millimeter wrenches e Philips head screwdrivers 2x200mm 2x100mm 1x80mm 0x60mm Bulldog 1x25mm Flat head screwdriver 70mm length 4x35mm Flat head bulldog screwdriver 4x20mm Socket extension 5 8 Calibration Test for the MTRE Temperature Calibration Unit The calibration test for the MTRE Temperature Calibration Unit must be performed once in 24 months with a calibrated multi meter Use the pair of test lead cables that are supplied with the MTRE Temperature Calibration Unit 11 8 Note The multi meter must be calibrated once in twelve months MTRE Advanced Technologies Ltd Thermoregulation Service Manual Thermostat Verification Tool The Thermostat Verification tool
65. egulation System should be performed only by MTRE Advanced Technology Ltd or authorized agents of MTRE Advanced Technology Ltd WARNING Detach the power cable before you do any maintenance or replacement proce dures Failure to do so could result in severe personal injury Introduction This chapter describes the hydraulic system of the Thermoregulation device The hydraulic system circulates water from the water tank through a filter pump heating cooling elements solenoid bypass valve Garment and back to the water tank Water flows through the internal connecting tubes in 2 circular loops Through the Garment e Through a solenoid valve to by pass the Garment directly into the water tank The hydraulic system consists of the following elements e Water Tank Assembly e Filter E Pump Solenoid Bypass Valve Water In and Water Out Connectors MTRE Advanced Technologies Ltd 7 1 Hydraulic System AA PS POutr VU Q as Mn Thermoregulation Service Manual Figure 7 1 Hydraulic Block Diagram Table 7 1 Hydraulic Block Diagram Elements Item No Qty Part No Description 1 2 002 00147 QCC Brass fem 1 4BSPT Viton 2 2 002 00148 Quick fitting 8mm BSPT fem str 3 2 002 00019 Quick Connector T 8mm 6mm 4 4 002 00158 Connector Plug in 8mm elbow 8mm 5 1 002 00176 Connector T to 8mm Tube 6 1 200 00128 S S Thermistor Housing 7 1 200 00104 W
66. egulation device are soldered to the board In case a fuse blows MTRE allows the service engineer the option of soldering a replacement fuse instead of replacing the controller board Fuses are purchased directly from the manufacturer Littelfuse Inc according to the catalog number listed in Table 6 3 See Chapter 9 Periodic Maintenance for fuse replacement procedure LED29 J4 LED 4 5 27 28 J8 J6 LED9 J10 P1 LED309 LED26 J2 J8 J1 LED3 J9 Ge ED15 LED13 Figure 6 4 Controller Board Component Placement Print Side Removal of Controller Board gt To remove the Controller Board see Figure 6 5 1 Remove the handle and the top cover see Chapter 5 Panels and Covers 2 Detach all the ribbon cables from the underside of the controller board by pressing the slide lock brackets MTRE Advanced Technologies Lid 6 7 Electrical System Thermoregulation Service Manual 3 With the extraction tool release all seven PCB spacer supports 4 Toremove the controller board slide it out from the side Note To re assemble the controller board follow the above procedure in reverse order Figure 6 5 Controller Board Assembly Table 6 4 Controller Board Parts Item No Qty Part No Description 1 1 300 00114 300 00118 Controller 2 Assembly 2 7 004 00029 PCB Spacer Support SCC 15 TEC Control Thermo Electric Components Board The TEC Control board is located under the MM
67. electrical shock MTRE Advanced Technologies Ltd All rights reserved Specification subject to changes without notice AMIRE A Member of Mennen Medical Group CritiCool Specification The CritiCool one of MTRE s Temperature Regulating systems induces maintains and reverses hypothermia in an effective and precise manner The desired tempera ture is preset by the physician with a possible range of target temperature from Hypothermia to Normothermia The system is composed of two elements the CritiCool device and the CureWrap The CritiCool device functions as a control unit constantly monitoring the Patients core temperature and as a cooling heating pump which brings the circulating water to the required temperature by using its on board body temperature control algorithm 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 area of the body thus allowing optimization of energy transfer HARDWARE Heat Exchangers e Peltier Technology TECs Water tank e Tap water usage e Tank Capacity 6 liters 1 6 gal Water Temperature e Water Temperature Accuracy 0 3 C 0 4 F e Water Temperature outflow 13 40 89C 55 105 4 F Pump e Water Circulating Pump e Pump Rate 1 2 L min e Protected by 263 micron filter Patient Temperature Channels e 2 Channels Core Surface e YSI 400 Series Probes e Body Temperature Range 15 C to 44 C 59 F to
68. ervice Manual Figure 6 10 Human Sensors Board Assembly Table 6 11 Humar Sensor Board Parts Item No Qty Part No Description 1 1 300 00016 Human Sensor Board 2 3 Nut Sensor Socket MMI Man Machine Interface The MMI receives e Input from the user via the soft touch buttons Output from the controller board and displays it on the interface screen The data 1s relayed via a ribbon cable to the controller board The connector of the ribbon cable is inside the MMI and cannot be disconnected without the removal of the back cover For removal of the MMI see Chapter 5 Panels and Covers Table 6 12 MMI Parts Item No Qty Part No Description 1 1 200 00062 Top Panel Assembly display and cover MTRE Advanced Technologies Ltd 6 15 Electrical System FP Board Thermoregulation Service Manual The FP board reads the measurement of pressure coming from the pump It receives power from the controller board power supply rectifies it and activates the piezoelectric transducers Table 6 13 FP Board Connector Identifier Type Description Ji Header 16 Power input from controller board output signals to controller board 6 16 Pressurstat Sensor indicated in the Technician Mode screen as Pres 2 Pressure Sensor indicated in the Technician Mode screen as Pres 1 Figure 6 11 FP Board Component Placement MTRE Advan
69. face Core C Accept Failed Temp C C 38 39 37 37 38 36 36 37 35 35 36 34 34 35 33 33 34 32 Thermostat Verification gt To check the thermostat 1 Remove the handle and the top cover see Chapter 5 Panels and Covers 2 Detach the thermostat sensor cable next to the water out sensor socket on the right side of the unit by pressing the latch 3 Connect the two pin Molex connector marked with the label GO on the Thermostat Verification Tool to the Thermostat socket on the Human Sensors board see Figure 9 1 9 6 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Thermostat Socket Figure 9 1 Thermostat Socket on Human Sensors Board 4 Ifthe Thermoregulation device remains in normal operation in this position after 10 seconds disconnect the Thermostat Verification Tool see Figure 9 2 from the Human Sensors board 5 Connect the two pin Molex connector marked with the label NO GO on the Thermostat Verification Tool to the Thermostat socket on the Human Sensors board 6 After 10 seconds in this position the machine activates the buzzer and the following message appears on the display HALT PLEASE RESTART 3 This indicates that the thermostat is within operating range If the buzzer is not activated and if the message does not appear on the display check the following 1 Check the resistance of the Thermostat Verification Tool with a Multi meter e On th
70. g e The special equipment supplied to perform the verification procedures described in Chapter 9 Periodic Maintenance Standard tools for normal maintenance The calibration test for the MTRE Temperature Calibration Unit Calibration Toolset Verification and Calibration Units Verification is executed by means of the Calibration Toolset while operating in Technician mode The Calibration Toolset consists of the components listed in Table 11 1 and are detailed in this section Table 11 1 Calibration Toolset Part No 017 00210 Item No Part No Description 1 017 00184 Temperature Calibration Unit 2 017 00284 Temp Probe Simulator TP400 3 017 00190 Analog Flow Pressure Calibration Unit 4 017 00290 Digital Pressure Calibration Unit Assy 5 017 00189 T E C Current Verification Unit 6 300 00093 Core Calibration Cable 7 300 00094 Surface Calibration Cable 8 017 00203 Downloading Plug 9 900 00127 RS 323 Communication Cable 10 11 017 00260 Download Cable With Plug MTRE Advanced Technologies Lid Special Equipment and Tools Thermoregulation Service Manual Table 11 1 Calibration Toolset Part No 017 00210 12 017 00211 Tool Box 13 005 00440 Red Probe for T E C Verification Unit 14 005 00441 Black Probe for T E C Verification Unit 15 017 00238 Mobile Thermometer Model 305 16 200 00096 Thermo couple 17 017 00229 Thermostat verification tool GO
71. g condition GO NO GO replace Human Sensor HS board Check HS harness HS Check Replace Thermistor Thermostat Replace controller board Complete Halt 5 System indicating a likely pro Perform re download Complete gram memory Replace controller board Complete Halt 6 or 7 Self test detected a problem with Perform self test again Heating Cooling unit Check Tec s consumption Replace TEC control board TEC Current test Replace TEC Transformer harnesses Halt 8 Self test detected no reading in Perform self test again Water in sensor Check Water in connector Replace water in connector Replace Water in thermistor Water sensor Replace HS board Verification Replace Controller board Complete Halt 13 System detected overpressure Check for tubes kinked Check pressure verification points Pressure Check FP harness Pressure Check Replace FP board Pressure Check the Solenoid Valve Pressure Replace controller board Complete 10 2 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Text Messages Note The Report Section columns in Table 10 2 indicate the relevant sections for reporting the action item in the Maintenance Verification Calibration or Service Reports Table 10 2 Text Messages Message Problem Possible Problem Action to be Taken Report Sec Add Water Bottom float sensor in the water tank is not activated Refill water Check float movement freely Check signa
72. g for technicians and sales personal as per the Intended use of the device or system The scope of the training is part of the agreement between MTRE or it s authorized distributer and or the end user Servicing of MTRE equipment is allowed only to persons that were trained and qualified to service the equipment efficiently and safely Warning No modification of this equipment is allowed Software update must be performed by service engineer authorized by MTRE MTRE Advanced Technologies Ltd iii Thermoregulation Service Manual MTRE Advanced Technologies Ltd Thermoregulation Service Manual TABLE OF CONTENTS Chapter 1 About This Manual Applicable Systems eec toc e uu sae teed E oM ert Re Pete a ne 1 1 TAMOS HD 1 1 Essential Performance RM 1 1 Chapter 2 Warnings and Precautions Definitions AS A A AAA eee 2 1 Intended Use A a A tet edt dii eid pe E eee AERE 2 1 MENDA 2 Precautions lr E NV EOD Piet Bie e Pa M ERR e fidt 2 2 Labelsz vase ite etis i tb e M red dane 2 4 Thermoregulation Device Labels esses eren enne nennen enne rra nnne nennen 2 4 Heter eple 2 4 Chapter 3 System Description General D seriptionskssadkssfesadkeuestneartaermedaresdeikeakagtnsraugvile 3 1 Thermoregulation Device 1 2 2 2 re nid ate e iere rete ee e D SEO A EE EA E E o EAR iS 3 1 External Features dada 3 2 Front VIEW Ive m 3 2 Side VIEW iuste ae o NEED
73. ical hazards and several changes in body temperature CAUTION The technical principles clinical applications and risks associated with circula tory 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 Thermoregulation system is mandatory WARNING U S Federal law restricts this device to sale by or on the order of a physician MTRE Advanced Technologies Ltd 2 3 Thermoregulation Service Manual Warnings and Precautions Labels Thermoregulation Device Labels 100 OPT99 CritiCool Advanced Ye 115v 57a sowon 2xT63A 250V 23ov 12 94 sosok 2 2 x T8 3A 250V zA amp amp Ro C O One of these labels SURFACE em 000000000000 100V 6 6A 50 60Hz xA EG Ro AB fade in israel 099 00163 Rev 01 Figure 2 1 Label Placement for the CritiCool Thermoregulation Device MTRE Advanced Technologies Lid Thermoregulation Service Manual Allon 2001 SURFACE ENJ 230 115v 50 60 Hz SOOW gt 2x6 3A T 250 ZAG d Bony CE n e Er 090000 fre OG Figure 2 2 Label Placement for the Allon Thermoregulation Device MTRE Advanced Technologies Ltd 2 5 Warnings and Precautions Thermoregulation Service Manual Table 2 1 Key for Label Symbols Symbol Description Location of core sensor socket T Locati
74. ingle thermistor unit assy water in 200 00132 Double thermistor unit assy w out thermostat 200 00131 ED B 6 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Flow amp pressure board 300 00015 Solenoid valve assembly 200 00078 Heating amp cooling unit assembly HCU 200 00054 Line filter 006 00002 MTRE Advanced Technologies Lid B 7 Thermoregulation Service Manual Part Number Description Transformer assembly 200 00059 200 00104 Right side cover 200 00143 B 8 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description LEFT SIDE COVER 200 00144 TOP COVER 200 00145 007 00352 REAR COVER 200 00146 MTRE Advanced Technologies Lid B 9 Thermoregulation Service Manual Part Number Description HANDLE 007 00365 Filter bracket 007 00334 Trolley front wheel with lock 007 00049 Trolley rear wheel 007 00047 B 10 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description TROLLEY ASSEMBLY 200 00141 Water out in female connector 200 00097 Service set of screws 200 00121 200 00119 MTRE Advanced Technologies Lid Thermoregulation Service Manual Part Number Descrip
75. ion Report under Wout B At the same time observe the maximum temperature readout on the External Temperature meter and list it in the report under Max Temp A Perform the calculation listed in the report A A B In the event that the result is inside the listed tolerance 1 0 proceed as follows a In the Technician mode screen press the bottom right button to toggle the TECs on and off b Observe the decrease in temperature on the External Temperature meter For each increment listed in the report 38 00 37 00 etc write down the corresponding temperature reading from the Technician Mode screen in the Wout and Win columns in the report See Table 9 2 for sample MTRE Advanced Technologies Ltd 9 5 Periodic Maintenance Thermoregulation Service Manual 16 Turn the Thermoregulation device OFF You have completed the Water Temperature sensors verification tests Summarize the verification results and check to see that they are within the tolerance If the verification tests pass proceed to Thermostat Verification on page 9 6 If the verification tests fail replace the faulty thermistor Refer to Section Thermistors on page 6 23 in Chapter 6 Electrical System for thermistor replacement procedure Table 9 3 Verification Form Water Temperature Sensors Max Temp C W out C A A B Accept Failed A B Measured Accepted 1 0 Temp C Max Min Sur
76. ions Element Eee Removal and re assembly Top Cover 6 The top cover provides access to the following elements Main controller e Power supply unit TEC controller Water in water out thermostat temperature sensor connectors The top cover is attached by means of four thumb captive screws and one M4x8 Philips head screw in the back of the unit To remove the top cover the handle must also be removed gt To remove the top cover 1 Unscrew the four screws by hand 2 Pull out the handle 3 Slide the cover out from the back of the unit gt To re assemble the cover Slide the back cover and replace the handle 2 Press in and screw the four thumb captive screws by hand do not use force when screwing to secure the handle and the top cover MTRE Advanced Technologies Ltd Thermoregulation Service Manual Table 5 1 Thermoregulation Device Elements and Removal Instructions Item Number Element in Figure 5 1 Removal and re assembly Handle 7 The handle allows easy transport of the Thermoregulation device It must be removed to enable removal of the top cover gt To remove of the Handle 1 Release the four thumb captive screws by hand 2 Pull up the handle gt To re assemble the handle 1 Slide the two ends of the handle into the holes in the the handle until the handle is inserted all the way in 2 Press in and screw the four thumb captive screws by ha
77. is working one TEC on each side of the Thermoregulation device 11 Heat Cool Denotes if the TECs are heating or cooling the water 12 Pump Denotes if the pump is operating 13 ThermoWrap ON Thermoregulation device pumps water to the Garment OFF The Thermoregulation device is on by pass 14 Use right button to toggle TECs TECs are ON OFF This function is used to switch OFF the heating cooling elements when checking water temperature sensors MTRE Advanced Technologies Ltd A 3 Thermoregulation Service Manual Entering Technician Mode Verification procedures listed Chapter 9 are performed while the Thermoregulation device is in Technician Mode gt To enter the Technician Mode 1 A 4 Turn the Thermoregulation device OFF for more than 10 seconds and then ON again for more then 10 seconds and then verify that self test is executed After a few seconds simultaneously press the Alarm Mute and Arrow Up keys This adds the Technician Mode to the menu Wait for Self Test to complete or skip to OPERATION by pressing the MODE key Press the MODE key to display the MENU Scroll down to TECHNICIAN and press the ENTER key to enter CORE NEONATAL x NM E 33 5 C TARGET TEMP 36 5 C aw OPERATION STAND BY SELECT MODE TEMP GRAPH PREFERANCE TECHNICIAN PEA Figure A 2 Technician Mode Available MTRE Advanced Technologies Ltd APPENDIX B SPARE PARTS LIST Disclaimer
78. ish Norwegian Danish User Interface GUI e 4 soft push buttons ACCESSORIES Temperature Sensors Reusable core Adult Infant Reusable surface Disposable core one size Disposable adapter core Disposable surface one size Disposable adapter surface CureWraps e Sizes range from 40 cm 196 cm 1 4 6 5 e Duration of use 72 hours e Each garment contains a 33mg chlorine tablet External Water Tubes e Adult Triple connector to garment e Pediatric Infant Dual connector to garment CliniLogger Optional e Up to 240 hours of CritiCool data storage e Connector DB9 F Type e CliniLogger Viewer software for PC REGULATORY e CE 0473 e Health Canada 64184 e FDA Clearance K083662 e EN 60601 1 e EN 60601 1 2 e Type BF Degree of protection against electrical shock e IP XO DGT 136 000 Rev C 05 2013 Page 1 1 AMTRE Member of Mennen Medical Group CritiCool Pro Thermal Regulation System Specification Servo controlled Non Invasive thermal regulation using water circulating CureWraps covering up to 85 of body surface CritiCool Pro is composed of two elements Thermal Regulation System The CritiCool amp the CureWraps Patient monitor The VitaLogik 4000 4500 Displays Mode of operation Set point temperature Core Temperature Surface Temperature Alarm displays Pump On Off icon Default mode e Mild Hypothermia Controller range e Water Temperature outflow 13 40 8 C 55 105
79. k see Drain the tank on page 7 6 2 Open the rear cover see Chapter 5 Panels and Covers 3 Disconnect the pump power connector 4 Disconnect the water in tube on the bottom of the pump coming from the water filter and the water out tube from the pump leading to the HCU connector of the pressurestat Press the release ring of each fitting and pull out the tubes 5 Loosen the four pump screws leaving them in their rubber washers These rubber washers are shock absorbers for the pump 6 Slide the pump out of the Thermoregulation device Note To re assemble the new pump follow the same procedure in reverse order CAUTION Do not over tighten the four pump screws Over tightening may cancel the effect of the shock absorbers MTRE Advanced Technologies Ltd 1 7 Hydraulic System Thermoregulation Service Manual Figure 7 6 Pump Removal Table 7 3 Pump Parts Item No Qty Part No Description 1 1 200 00115 Pump Assembly 2 4 009 00009 Screw M4x16 Pan Philips s s 3 1 007 00232 Pump Shock Absorber MTRE Advanced Technologies Lid Thermoregulation Service Manual Pump Block Diagram Detail A Figure 7 7 Pump Block Diagram Table 7 4 Pump Block Parts Item No Qty Part No Description 1 1 200 00115 RD5 Pump Assembly 2 2 002 00027 Quick Angle Connector for Tube 8mm 3 1 005 00156 Connector Male 3 pin Crimp Panel Mount 4 2 005 00159
80. l on float switch on J3 pins 5 amp 3 If there is no signal replace water tank assembly Replace 300 00091 Level sensor harness CHECK WATER CONNECTION Pressure at Water out exceeds 0 9 bar Connect ThermoWrap Check fuse F5 solenoid valve Check fuse F8 12V Pressure Check FP board and cable to con troller board Complete CHECK CORE SEN SOR Wrong decoding of sensor plug Connect proper sensor Replace core sensor with the one supplied with the system HS Use a new core sensor Check HS board and harness HS MTRE Advanced Technologies Ltd 10 3 Troubleshooting Thermoregulation Table 10 2 Text Messages Service Manual Message Possible Problem Action to be Taken Report Sec Problem CHECK SURFACE Wrong decoding of sensor plug Connect proper sensor SENSOR Replace surface sensor with the HS one supplied with the system Use a new surface sensor Check HS board and harness HS CONNECT CORE No core sensor detected Replace core sensor SENSOR Check HS board and harness HS CONNECT SUR No surface sensor detected Replace surface sensor HS FACE SENSOR Check HS board and harness HS WATER TEMP TOO Water temperature below 10 C If water temperature is not below HS LOW 10 C check HS board and harness WATER TEMP TOO Water temperature above 42 C If water temperature is not above HS HIGH 42
81. ld 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 consequential damages ii MTRE Advanced Technologies Ltd Thermoregulation Service Manual Use of Manual The MTRE Thermoregulation system described in this manual has been designed to meet international safety and performance standards Only qualified personnel may service the system and these field engineers must first have a full understanding of the proper operation of the system The purpose of this manual is to help qualified personnel understand and service the system It is important that you read this manual and familiarize yourself thoroughly with its contents before you attempt to service 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 further clarification The information provided in this manual is not intended to replace regular medical training procedures Field Repairs Statement Repair of MTRE Equipment in the field will be performed by service engineers authorized by MTRE Repair will be performed on a board level only The list of replaceable component and boards is available in the spare part list Appendix B System testing will be performed using the test form available in the Service manual Training and Qualification MTREor it s authorized distributer will provide trainin
82. m must complete the Thermoregulation training program The repair and servicing of the Thermoregulation 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 Thermoregulation 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 Thermoregulation device sounds an alarm and or presents a display other than the standard MTRE display the operator should proceed according to the display message and or the troubleshooting instructions see Chapter 10 Troubleshooting Avoid folds in the Garment these may obstruct water flow 2 2 MTRE Advanced Technologies Lid Thermoregulation Service Manual Do not block the Thermoregulation device ventilation grills Air must be able to flow freely in and out in order to the 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 WARNING Improper use of the Thermoregulation systems may lead to skin burns electr
83. n cable P N 300 00093 red and black jacks to the Thermoregulation device Toggle the Calibration Verification switch to Calibration on P N 017 00184 Turn the Human Sensor Calibration switch to 36 7 C For the CritiCool system toggle the Calibration Verification switch to 39 89C with P N 017 00284 pick 38 0 as the Core temperature This state is intended to simulate the patient temperature of 36 79C or 39 8 or 38 0 with P N 017 00284 on the CritiCool system with the desired set point of 40 C In this state the Thermoregulation device heats at its full capacity Note 10 11 12 13 14 I5 Make sure that the Thermoregulation device is in Technician mode Connect the external bypass tube with the Thermocouple 200 00096 to the Water out connector under core socket and to the Water in Connect the External Temperature meter P N 017 00238 to the Thermocouple and turn it ON Observe the Water Out line displayed on the Technician Mode screen Wait a few minutes until the temperature reaches its maximum Observe the maximum temperature of Water out on the Technician screen and max temperature on external Thermometer Write down the values on report A B and then press the right button on the display to turn off the Heating Cooling elements Observe the Water Out temperature displayed on the Technician Mode screen and list the maximum temperature reading in the attached Maintenance Verification Calibrat
84. n erret nennen nnns 9 2 Human Sensors Verification sese eene enne e reser nre nnne nens 9 2 Water Temperature Sensors Verification sse enne enne nnn nennen 9 4 Thermostat Verification A uade cis t Htec ndo ias 9 6 Pressure Verification 22 2 de ge eL Re DUE GO oe PU c o mete EA LE 9 8 TEC Current Test 53e vo ee e nre ee Aae ke ART a A 9 9 Check for Water Eeakage eode eei rede eer eie baee e e 9 11 Selfstest o tb aeta e e RU NEN EM EN EN red P Ie SONNE 9 11 Replacing Controller Board Fuses esses enne erret 9 11 Chapter 10 Troubleshooting Hal Messages C M 10 1 Text M SSages una et 10 3 Chapter 11 Special Equipment and Tools Calibration Toolset Verification and Calibration Units essen 11 1 MTRE Temperature Calibration Unit P N 017 00184 oo cceccceseceeeeeeeesecseeceseseeceeeeessecseeneesseeeaes 11 2 MTRE Temperature Calibration Unit Controls esses ener 11 2 Analog Flow and Pressure Calibration Unit P N 017 00190 esrrronrrnnvrnnrrennrenrrnnrsnrernrrrssrrnsessrssnrrenenn 11 4 Digital Pressure Gauge P N 017 00290 sse ener enne 11 4 TEC Current Verification Unit ener enne nennen en reset nnn ener nnns 11 6 Calibration Cables ici ie cr e tee re ie ed e eee ere e tem dr so FO ed esee dee EET 11 7 Core Calibration Cable 5t toe Ere ai 11 7 Surface Calibration Cable 2 52 55 5 pat RR RO INI ED
85. n power rectifying circuit The following table lists all main power distribution components on the controller board Table 6 2 Controller Board Power ON LEDs on the Controller LED LED Indication Remarks Identifier LED 6 Vent 1 Vent voltage LED 3 Vent 2 Vent voltage LED 30 Com cable Indicates RS 232 cable connector LED 26 Com 5v LED 9 VCC LED 29 LCD 12V LED 4 X3 Over pressure pump LED 27 X1 Communication LED 28 X2 Communication LED 5 AUX Not in use LED 15 12V Voltage indication LED 13 12V Voltage indication LED 10 Pump Pump voltage MTRE Advanced Technologies Ltd 6 5 Electrical System Thermoregulation Service Manual Table 6 2 Controller Board Power ON LEDs on the Controller LED 7 Sol 2 Solenoid voltage D2 Fan Voltage type D2 Allon amp CritiCool Table 6 3 Controller Board Connectors Identifier Type Description J4 DB37 socket MMI connector J6 J8 DB15 socket TEC board control right and left JO DB15 socket FP board connector J10 DB15 socket Human Sensors board connector P1 DB9 socket RS 232 connector J1 Header Left side FAN and pump J3 Header Right side FAN solenoid and water level float position J2 Header Power Supply Assembly connector MTRE Advanced Technologies Ltd Thermoregulation Service Manual Controller Board Fuses Controller board fuses of the Thermor
86. nd do not use force when screwing to secure the handle and the top cover Figure 5 3 Cover Assembly top cover pay attention to the direction of the curve in MTRE Advanced Technologies Lid 5 7 Panels and Covers Removal of the Trolley gt Toremove the trolley 1 Empty the water tank 2 Place the Thermoregulation device on its side Thermoregulation Service Manual 3 Unscrew the six Phillips head screws and washers that secure the trolley to the main chassis To re assemble the trolley follow the above procedure in reverse order Make sure that you tighten the screws with the washers Figure 5 4 Trolley Assembly Table 5 2 Trolly Parts Note Assemble the trolley with the braked wheels in front Item No Qty Part No Description 1 6 009 00034 Screw M6x12 Pan Philips s s 2 6 010 00025 Spring Washer M5 s s 3 1 200 00067 Allon Trolley 200 00141 CritiCool Trolley MTRE Advanced Technologies Ltd CHAPTER 6 ELECTRICAL SYSTEM This section outlines the electric and electronic systems that control the functioning of the Thermoregulation system WARNING Detach the power cable before you do any maintenance or replacement proce dures Failure to do so could result in severe personal injury CAUTION Before performing any procedure in this chapter use an ESD Electrical Static Discharge wrist strap to connect yourself to the chassis of the device
87. nenssvnnenssvsnenssvnnenssvnenssvnnnee D 1 For Stimulator MTRE Temperature Calibration Unit sess D 5 Appendix E Downloading Updated CritiCool Software vii MTRE Advanced Technologies Ltd CHAPTER 1 ABOUT THIS MANUAL Applicable Systems This Service Manual covers all Normothermia management and Cooling Therapy systems produced by MTRE Advance Technology Ltd To avoid confusion all systems will be referred to in this manual as the Thermoregulation System Information component descriptions or procedures specific to any particular system will be noted within the manual in the relevant section Garments The Thermoregulation System is designed to function with both the ThermoWrap and the CureWrap systems Both ThermoWrap and CureWrap will be referred to in this manual as the Garment Information specific to any one of these Garments will be noted within the manual in the relevant section Essential Performance The following functions are considered by the manufacturer as essential Water temperature control s Unexpected core temperature alarm WARNING The system will HALT if any of these elements of the control mechanism fail MTRE Advanced Technologies Ltd 1 1 About This Manual Thermoregulation Service Manual 4 2 MTRE Advanced Technologies Lid CHAPTER 2 WARNINGS AND PRECAUTIONS Definitions WARNING Indicates a condition that may endanger the patient or the system operator CAUTION
88. nsor 014 00020 1 SURF Sensor YSI B C GREEN 014 00021 1 Accessories Box 015 00035 1 Filter Assy 200 00130 1 CureWrap Connecting Tubes 200 00147 1 Quick Reference Guide English 014 00082 1 Label Set Multilanguage 200 00142 Table 4 5 Acc Kit for Infant with Reusable Temperature Sensors 200 00320 QTY Description Part Number T Connector 1 4 with hose barb 002 00069 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Table 4 5 Acc Kit for Infant with Reusable Temperature Sensors 200 00320 1 Interface Cable for Disp Core Sensor 014 00028 1 Interface Cable for Disp SURF Sensor 014 00029 1 Accessories Box 015 00035 1 Filter Assy 200 00130 1 CureWrap Connecting Tubes 200 00147 1 Quick Reference Guide English 014 00082 1 Label Set Multilanguage 200 00142 Table 4 6 Acc Kit for Infant with Interface Cables Only for Disposable Sensors 200 00330 QTY Description Part Number 1 Connector 1 4 with hose barb 002 00069 1 Interface Cable for Disp Core Sensor 014 00028 1 Interface Cable for Disp SURF Sensor 014 00029 1 Accessories Box 015 00035 1 ThermoWrap Connecting Tube 200 00109 1 Filter Assy 200 00130 1 Quick Reference Guide English 014 00082 1 Label Set Multilanguage 200 00142 Moving the Unit Preparation Prior to moving the unit 1 Ensure that the Thermoregulation device is off by
89. o 77 F 9 Body temperature 0 C to 45 C 32 F to 113 F Accuracy 0 1 C over the entire range Digital Sample Rate 160 Hz Sample Resolution 24 bit Frequency Response 0 to 15 Hz Cardiac Output Determination Range 0 to 20 liters per minute Injectate Volumes 1 3 5 and 10cc Displayed Data Cardiac Output Cardiac Index Stroke Volume Stroke Volume Index Blood Temperature Injectate Temperature Trial Number Data Storage DGT 136 001 Rev B 7 2012 Page 3 3 In Cardiac Output mode Cardiac Output 0 Hemodynamic Calculation results Measuring time In Two Temp mode Temperatures and Delta Temp 0 Temperature Alarms Non Invasive Blood Pressure Oscillometric Method Displayed Parameters Systolic Diastolic Mean pressure values Time of last measurement measurement interval cuff size and heart rate Cuff Size Adult Pediatric Infant Neonatal Inflation Rate Within 5 sec Initial inflation target 150 mmHg Adult Pediatric Initial inflation target 100 mmHg Neonatal Over pressure limit 290 mmHg Adult Pediatric Over pressure limit 145 mmHg Neonatal Cycle Times Deflation time typical 30 sec BP time out 60 180 sec Measurement Ranges Adult in mmHg Systolic 30 to 255 Diastolic 15 to 220 Mean 20 to 235 Measurement Ranges Neonatal in mmHg Systolic 30 to 135 Diastolic 15 to 110 Mean 20 125 Modes Auto Manual STAT Automatic intervals 1 2 3 4 5 10 15 20 30 60 120 180 2
90. ocedure in reverse order MTRE Advanced Technologies Ltd 6 3 Electrical System Thermoregulation Service Manual Figure 6 3 Power Supply Assembly Table 6 1 Power Supply Parts Item No Qty Part No Description 1 1 200 00059 Power Supply Assembly 2 6 009 00006 Screw M4x8 Pan Philips s s 3 4 010 00013 Spring Washer M4 s s Controller Board The controller board monitors all system functions performs all the internal algorithms and converts analog signal received from the sensors to digital input The controller board contains the following components controller 870552 RAM ROM e Flesh Memory e Address and data components e X Voltage regulators e Very Fast Acting type fuses Rectifiers LEDs RS 232 Communication Port Audible alarm The controller board receives input from the Human Sensors Water Temperature sensors FP board e Power Supply Assembly Water level sensor MMI RS 232 Communication Port It controls output to the MTRE Advanced Technologies Ltd Thermoregulation Service Manual TECs e MMI the display Solenoid bypass valve Pump Fans RS 232 Communication Port The controller board incorporates the power distribution circuit Power from the transformer is rectified and supplied to the Controller board MMI FP Board Human Sensors Board The TEC control has its ow
91. on knob to 36 2 Adjust the set point temperature to 37 C The system heats up to 40 8 C Water out Use a multi meter set to DC current with the pair of test cables from the MTRE Temperature Calibration Unit Insert the probes of the cables to the pair labeled 1 of sockets in the TEC Current Verification Unit Measure the current and note the results MTRE Advanced Technologies Ltd Thermoregulation Service Manual 12 Repeat the procedure for every pair of sockets on the TEC Current Verification Unit 13 Lower the set point temperature to 34 C the system cools 14 Repeat the measurement for all four TECs Note The average current of all four pairs should be a minimum of 3 Amps If any of the TECs are found to be out of tolerance check the TECs and the TEC control board gt To verify the fault of the TECs or of the TEC control board 1 Turn the Thermoregulation device OFF 2 Remove the TEC Current Verification Unit cable from connector J1 Leave the cable leading from the HCU connected to the TEC Current Verification Unit cable with the connector 3 Detach the cable leading from connector J21 on the TEC control board to the HCU 4 Insert the plug of the TEC Current Verification Unit cable J2L on the TEC control board 5 Turn the Thermoregulation device ON 6 Measure the current in all four pairs of sockets as performed previously If any of the TECs are still found to be out of tolerance replace the HCU
92. on delivery The device 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 device 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 To assemble the handle 1 Release the four thumb captive screws from the handle MTRE Advanced Technologies Ltd 4 1 Installation Thermoregulation Service Manual 2 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 Figure 4 1 3 Press in and screw the four thumb captive screws by hand do not use force when screwing to secure the handle and the top cover Thumb Captive Screws 4 Y ES Be Figure 4 1 Handle Assembly MTRE Advanced Technologies Ltd Thermoregulation Service Manual Accessory Kits Note Refer to User s Manual for the equipment list specific to the Thermoregulation model The Thermoregulation system includes one of the following accessories kits Allon 2001 Accessory Kits Table 4 1 Acc Kit for Adult with Reusable Temperature Sensors 200 00400 QTY Description Part Number 1 Connector 1 4 with hose barb 002 00069 1 Adult Eso Rectal Core Sensor 014 00020 1
93. on of surface sensor socket Pr AC Voltage Fuse C The CE mark of conformity indicates that the product has received the European approval for MDD 93 42 EEC 0473 Equipment not suitable in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide See User Manual Type BT equipment Date of manufacture Mfg 2005 GB The CSA symbol indicates that the product has received the approval of 7 the C us Canadian Standards Association XX yyyy Machine Version Machine serial number Water in connector indicator No Pushing C Water out connector indicator V 2 6 MTRE Advanced Technologies Ltd Thermoregulation Service Manual System Description CHAPTER 3 SYSTEM DESCRIPTION General Description MTRE s Thermoregulation system induces maintains 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 Mild Hypothermia to Normothermia The system is composed of two elements the Thermoregulation device and the Garment The Thermoregulation 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 poin
94. or hy e p C Water Level Indicator Figure 3 1 Front View MTRE Advanced Technologies Ltd Thermoregulation Service Manual Side View Top Cover with Air Grille Lower Side Cover Figure 3 2 Side View MTRE Advanced Technologies Lid 3 3 System Description Thermoregulation Service Manual Rear Panel Thumb Captive Screws 4 Air Outlet Grille 6mm Threaded Hole for Equipotentiality Location Three prong Connector RS 232 Comm Connector Tumb Captive Screws 2 Figure 3 3 Rear View Accessories To operate the Thermoregulation system the following accessories are needed 1 Human Temperature Sensors 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 device The core sensor must be inserted into the patient s body and the surface sensor must be attached to the patient s skin for the device to function properly e Disposable Sensors Disposable sensors are attached to two color coded adapters gray Core and green Surface The core sensor must be inserted into the patient s body and the surface sensor must be attached to the patient s skin for the device to function properly Sensors and adapters are guaranteed for one year 3 4 MTRE Advanced Technologies Ltd Thermoregulation Service Manual WARNING
95. pressing the ON OFF switch 2 Ensure that all electrical connections are disconnected MTRE Advanced Technologies Lid Installation Thermoregulation Service Manual Locking and Unlocking the Trolley Wheels The Thermoregulation device trolley has four wheels The front wheels are fitted with a brake The brake lever is located over the wheel To lock firmly depress the lever To release lift the lever When the unit is stationary the brakes must be in the locked position Release the brakes only when transporting the unit Storage Conditions and Transport Storage Environment Store the Thermoregulation device in a clean and dry area with An ambient temperature of 40 C to 70 C 40 F to 158 F Arelative humidity range of 10 to 100 including condensation e An atmospheric pressure range of 500 hPa to 1060 hPa Note Disconnect connecting tubes and sensors when the device not in use Drain the water and keep the water tank top open 4 6 MTRE Advanced Technologies Ltd CHAPTER 5 PANELS AND COVERS Introduction This chapter contains a description of Which element of the Thermoregulation device can be accessed by each cover The instructions for removal and re assembly of each cover Figure 5 1 Covers Assembly MTRE Advanced Technologies Ltd 5 1 Panels and Covers Thermoregulation Service Manual 1 Table 5 1 Thermoregulation Device Elements and Removal Instructions
96. r to TECs J2L Header 8 Power to TECs J6 Header 4 AC power from transformer J5L Header 4 AC power from transformer J19 Molex 9 pin Controller JTAG Right Side J20 Molex 9 pin Controller JTAG Left Side Table 6 7 TEC Control Board Led undicators Identifier Meaning Note CR5 Right Side TEC NUM 1 Cooling Green Heating Red CR6 Right Side TEC NUM 2 Cooling Green Heating Red CR7 Right Side TEC NUM 3 Cooling Green Heating Red CR8 Right Side TEC NUM 4 Cooling Green Heating Red MTRE Advanced Technologies Ltd 6 9 Electrical System Thermoregulation Service Manual Table 6 7 TEC Control Board Led undicators CR9 Left Side TEC NUM 1 Cooling Green Heating Red CR10 Left Side TEC NUM 2 Cooling Green Heating Red CR11 Left Side TEC NUM 3 Cooling Green Heating Red CR12 Left Side TEC NUM 4 Cooling Green Heating Red CR3 Left Side Bridge1 Voltage Indication Green Orange OK OFF Fault CR4 Left Side Bridge2 Voltage Indication Green Orange OK OFF Fault CR1 Right Side Bridge1 Voltage Indication Green Orange OK OFF Fault CR2 Right Side Bridge2 Voltage Indication Green Orange OK OFF Fault Figure 6 6 TEC Control Board Component Placement MTRE Advanced Technologies Ltd Thermoregulation Service Manual Figure 6 7 TEC Control Board Component Placement gt To remove the TEC Control Board See Figure 6 8 1 Remove the handle and the
97. r towards you and then down to release the lip from the chassis gt To re assemble the rear cover 1 Insert the lip at the top of the cover into the unit 2 Tighten the two screws at the bottom of the cover MTRE Advanced Technologies Ltd Thermoregulation Service Manual Table 5 1 Thermoregulation Device Elements and Removal Instructions Element Item Number in Figure 5 1 Removal and re assembly Bottom Front Cover 5 The bottom cover provides access to the water in and water out tubes leading from the bottom of the water tank To remove the water tank it is necessary to remove the bottom front cover gt To remove the Bottom Front Cover Remove the handle 2 Remove the top cover 3 Remove the right and left side covers see page 5 2 to expose the two M4x8 Philips head screws that secure the bottom front cover 4 Unscrew the two M4x8 Philips head screws one on each side of the cover 5 Carefully place the Thermoregulation device on its side 6 Unscrew the 2mm Allen screw located at the bottom front edge of the trolley gt To re assemble the cover 1 Return the cover and tighten the 2mm Allen screw and the two Philips head screws 2 Re assemble the right and left side covers MTRE Advanced Technologies Lid 5 5 Panels and Covers Thermoregulation Service Manual Table 5 1 Thermoregulation Device Elements and Removal Instruct
98. rews 200 00121 200 00119 200 00109 B 28 MTRE Advanced Technologies Ltd APPENDIX C SERVICE FORM For technical assistance service request fill the following form and send to neomi mmi co il MTRE Advanced Technologies Ltd C 1 MITRE Advanced Technology LTD A 4 Hayarden Street Yavne P O B 102 Rehovot 76100 Israel y j Tel 972 8 9323333 Fax 972 8 9328510 Service Call Technical Assistance Request Form To Technical Support Department neomi mmi co il Date id A Customer Details x From E mail Firm Name Fax tt B Technical Problem Details Model Unit Part Description Serial Software B1 Top Assembly Parameter Sub Unit Part Description Serial Q ty B2 1 Sub Assembly 1 B2 2 Sub Assembly 2 Fault Description full details B2 3 C Customer Request C1 O Exchange gt RMA Price Delivery C2 O Send For Repair RMA Price Delivery C3 O Buy Item Price Delivery C4 Information Customer Order Number if Exchange or Repair C5 Replacement Part if exch Description Serial S W Needed C6 For Mennen Internal use only MRB YES NO D Shipment Instructions Customer request after repair or exchange D1 O Fedex Courier D2 O Airfreight D3 O Other ACG 000 023 Rev A Service call technic
99. ry Translation Hexadecimal Binary Decimal 1 0001 1 2 0010 2 3 0011 3 8 4 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Table 8 3 Hexadecimal to Binary Translation Hexadecimal Binary Decimal 4 0100 4 5 0101 5 6 0110 6 7 0111 7 8 1000 8 9 1001 9 A 1010 10 B 1011 11 C 1100 12 D 1101 13 E 1110 14 F 1111 15 MTRE Advanced Technologies Ltd 8 5 Software Thermoregulation Service Manual 8 6 MTRE Advanced Technologies Ltd CHAPTER 9 PERIODIC MAINTENANCE WARNING The repair and servicing of the Thermoregulation System should be performed only by MTRE Advanced Technology Ltd or authorized agents of MTRE Advanced Technology Ltd WARNING Follow all safety guidelines as described in Chapter 2 Warnings and Pre cautions Failure to do so can cause serious personal injury Note At the end of any maintenance procedure connect a tube to bypass the Garment and conduct a complete self test This is to guarantee that the system is operational Overview of the Periodic Maintenance Procedures This chapter describes the periodic maintenance procedures performed on the Thermoregulation device Periodic maintenance should be performed every twelve months The following steps outline the routine procedures in periodic maintenance Entering Technician Mode see Entering Technician Mode on page A 4 Draining Water
100. s Numerical Trend Graphic Full Disclosure All leads ECG waveform Overview All Waveforms with top ECG Event Strips 20 Seconds of all ECG and Vital signs waveforms 10 sec pre amp post event Storage Basic 1 GB Optional 8 GB Optional 16 GB Default Alarms e User defined e Fixed or calculated values e Alarm levels 9 Clinical levels C1 C2 C3 C4 9 Technical levels T1 T2 Recorder Optional e Integrated Recorder up to 3 channels Analog Output 4 channel e ECG II 1Volt mV e ECG V1 1Volt mV e QRS 5 Volt e ART 1Volt 100 mmHg Clinical Specifications ECG 3 5 12 Lead Leads ECG cables for 3 5 10 lead surface ECG with defibrillation protection in the cable Input Dynamic Range 5 mV peak to peak Input DC Offset 530 mV Baseline Correction Automatic recovery of waveform within 100 msec Notch Filtering Custom 50Hz or 60Hz Frequency Response 0 Diagnostic 0 05 to 150Hz 0 Monitoring 0 5 to 40Hz ST 0 05 to 40Hz Exercise 1 to 25Hz Sensitivity 0 25 0 5 1 0 2 0 4 0 8 0 mV cm Common Mode Rejection 120 dB minimum Noise 30 pV Input Impedance 2 5 mega Defibrillator Pulse Protection Yes Baseline Recovery 8 sec Lead Fault Sense Based on impedance with driven lead Digital Sample Rate 640Hz Sample Resolution 24 bit Pacemaker Detection and Rejection of Pacer Artifact Pacer Detection Flag inserted into ECG waveform 3 Detection Modes 1 Fixed Threshold 2mV 2
101. s access to the following components HCU Heating Cooling Unit No 1 Water in temperature sensor The right side cover provides access to the following components HCU Heating Cooling Unit No 2 Water out temperature and thermostat sensors Solenoid by pass valve gt Toremove the Side Covers see Figure 5 1 1 Unscrew the three M4x8 Philips head screws on the top lip and the two screws in the back of the cover the front end of the cover so that it clears the Quick Coupling Connector side of the cover Figure 5 2 Side Cover Removal Slightly release the cover from the back and rotate Release the two 2mm Allen screws at the bottom MTRE Advanced Technologies Lid 5 3 Panels and Covers Thermoregulation Service Manual Table 5 1 Thermoregulation Device Elements and Removal Instructions Element Eee Removal and re assembly gt To re assemble the side covers 1 Position the slot in the front to fit around the Quick Coupling Connectors 2 Align the back end 3 Tighten all screws Rear Cover 4 The rear cover provides access to the following FP circuit board Pressure tubes Pressurestat tube Pump The top of the cover is inserted into a slot in the frame of the unit and the bottom is attached with two Thumb Captive screws gt To remove of the Rear Cover 1 Unscrew the two thumb captive screws at the bottom of the cover 2 Pull the bottom part of the cove
102. sores protective means between the operating table and the Garment 7 Before initiating maintenance procedures as described in Chapter 9 disconnect the power cable from the power source 8 The default setting is intended to maintain normothermia However the system provides the physician with the option of selecting a body temperature in the range of 30 C to 40 C 86 F to 104 F 9 Do not lift or move the patient by means of the Garment This may cause tearing and water leakage 10 Use reusable core sensors or disposable sensor adapters supplied by MTRE or YSI series 400 compatible sensors 11 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 Thermoregulation system is mandatory 12 Repair and servicing of the Thermoregulation System should be performed only by MTRE Advanced Technologies LTD or authorized agents of 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 Thermoregulation System All hospital personnel using the Thermoregulation syste
103. sure of the Thermoregulation device at 0 9 bar and at 1 1 bar The Flow and Pressure Calibration Unit has two connecting tubes with a valve flow meter and pressure gauge ANIRE UU FLOW PRESSURE CALIBRATION UNIT Not Irt use In Machine Verslon 05 ES 2 NS ft Il Figure 11 2 MTRE Flow and Pressure Calibration Unit Digital Pressure Gauge P N 017 00290 Figure 11 3 Digital Pressure Gauge P N 017 00290 gt To install the digital pressure gauge 1 Connect w out Figure 11 4 and w in Figure 11 5 tubes to the gauge panel according to Figure 11 4 MTRE Advanced Technologies Lid Thermoregulation Service Manual 11 3 The labels on the panel indicate where to connect the tubes Figure 11 5 Figure 11 5 W IN The pressure gauge is connected and ready to use MTRE Advanced Technologies Lid 11 5 Special Equipment and Tools Thermoregulation Service Manual Figure 11 6 Pressure Gauge connected WARNING Do not change the setting of the gauge the gauge is calibrated according to the transducer connected and the fixed setting as you received it TEC Current Verification Unit The TEC Current Verification Unit tests the current sent to the TECs on both sides of the Thermoregulation device from the TEC control board The TEC Current Verification Unit has two cables The cable with the plug is inserted to connectors J1 and J2L of the TEC current board The cable with the conn
104. t eo ia n elias 7 5 Installing the New Filter eie a e ete e He la cesses choses e Re E D tend 7 6 Pump earo 7 7 Removing the Pump aere er ne bna E etg A E E EE eerte ege ee t dt 7 7 Pump Block Diagram einen sen hit tettit iie e EE P GREECE S I Te RTT Le de EUR Pod 7 9 Solenoid Bypass Valve ccceccecsscessessscessceseeeseeeseceseseeeseseesaecsaecsecseeseceeseecsseeseceseceseeeseeesecesecneeeseneenseengs 7 9 Water In and Water Out Connectors sese etn nnne n reete ener nns 7 10 Chapter 8 Software ONCE atate tee RGT 8 1 Seles reser 8 1 Safety Algorithm 2 tette diee eU n d deir d eee ir P d PORE ISTE 8 1 Halt Condit19ns 2 3 05025 aches Hahah hla chen ented E 8 2 Technician Mode Error Messages ccccssccsssceseesseeeseeesecssenseceseceeeeeseeesaecaeceaeceseeeaeeeseesaeceseseeeeeeeesaessaees 8 3 Explanation of Error Messages 1i eet dae n ciere et ie ra e Pee rv er e Fee ee redu Pee se edu da 8 3 V MTRE Advanced Technologies Ltd Thermoregulation Service Manual Chapter 9 Periodic Maintenance Overview of the Periodic Maintenance Procedures ccecccecscesseessecseceeeceeeeeseecscenseceseceseeeseecseceaeenseenas 9 Removing the Cover A RC Tee ET OE dote ue Ue dae venere oe ei e qe eee ine et 9 2 Replacing the Water Filter 5 ee ete et ir E ak Toa ed a e aE Ed eee de 9 2 Activating the CritiCool Machine esses eene nenne
105. t temperature The cooling heating pump brings the water to the required temperature and the pump circulates it through the specially designed Garment The Garment 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 The MTRE garment is proprietary to MTRE and this is the only garment authorized to be used with the Thermoregulation Device Thermoregulation Device The Thermoregulation device has a microprocessor that controls the water temperature to 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 Thermoregulation device is equipped with a handle for easy transport CAUTION Never place the Thermoregulation device on its rear or side MTRE Advanced Technologies Ltd 3 1 System Description External Features Front View gt Waterin Quick Coupling Connector N a Water Tank Cap P N 3 2 Thermoregulation Service Manual A mE A Handle d M A _ iip Adjustable Control Panel Core Sensor 5 e Socket Water out y Quick Coupling Connect
106. through the module it attempts to establish a new equilibrium within the materials The analog signal treats the first material as a hot junction needing to be cooled and the second material as a cold junction needing to be heated Since the material is actually at the same temperature the result is that the hot side becomes hotter while the cold side becomes colder The direction of the analog signal determines if a particular side will cool down or heat up In short reversing the polarity will switch the hot and cold sides Heat Sink The purpose of the heat sinks is to dissipate the heat or cold created by the thermal exchange elements as quickly as possible The capability of the TEC to either heat or cool depends on the level of temperature on the side of the heat sink If it is very cold on that side its ability to heat is diminished The faster the heat or cold are dissipated the faster the Thermoregulation device reaches the required water temperature Fan The fans remove the heated or cooled air dissipated through the heat sinks The air is drawn in from the bottom grille and expelled through the grilles in the top cover and in the rear of the Thermoregulation device The fans receive power directly from the controller board gt To remove the HCU See Figure 6 16 6 20 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Note Before you start place a cloth on a flat surface Turn the Thermoregulation device on
107. tion Connecting water tubes 2 by 2 way metal connectors 200 00109 Female connector for connecting water tubes 002 00124 Connecting water tubes 2 by 3 way metal connectors 200 00147 B 12 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Drain Tube 020 00013 Buffer Tube 200 00069 Image not available Draining Qcc 002 00069 Qc T 8X6X8 002 00019 MTRE Advanced Technologies Lid Thermoregulation Service Manual Part Number Description Surface sensor B m Core sensor 014 00020 Surface sensor adaptor cable 014 00029 Core sensor adaptor cable 014 00028 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Pediatric core sensor 014 00005 Fuse 7A pack of 10 005 00483 Image not available Power cord 014 00016 Image not available Reusable packaging for Allon 2001 015 00062 Image not available SOLENOID VALVE COIL 003 00011 SOLENOID VALVE ASSEMBLY 200 00122 MTRE Advanced Technologies Lid Thermoregulation Service Manual Part Number Description SOLENOID PLUG 003 00012 Calibration Verification Tool Set 017 00210 Image not available Calibrating the Tool Set at the Factory Labor Only 017 00240 Image not available Digital Pressur
108. y water in 200 00132 Double thermistor unit assy w out thermostat 200 00131 i ED B 22 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Flow amp pressure board 300 00015 Solenoid valve assembly 200 00078 Heating amp cooling unit assembly HCU 200 00054 Line filter 006 00002 MTRE Advanced Technologies Lid B 23 Thermoregulation Service Manual Part Number Description Transformer assembly 200 00059 Water tank assembly 200 00104 Right side cover 200 00112 B 24 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Left side cover 200 00113 Top cover 200 00133 Front lower cover 007 00243 MTRE Advanced Technologies Lid B 25 Thermoregulation Service Manual Part Number Description Rear cover 200 00135 Handle 007 00333 Filter bracket B a B 26 MTRE Advanced Technologies Ltd Thermoregulation Service Manual Part Number Description Trolley front wheel with lock 007 00049 Trolley rear wheel 007 00047 Trolley assembly 200 00067 Water out in female connector 200 00097 MTRE Advanced Technologies Lid B 27 Thermoregulation Service Manual Part Number Description Service set of sc

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