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Model 2000 Service Manual

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1. Field Definition Units or Range of Values PT1 Patient Temperature 1 C PT2 Patient Temperature 2 C FL Water Flow Rate ml min T1 Monitor Water Temperature C T2 Control Water Temperature C T3 Return from Pad Water Temperature C T4 Chiller Loop Water Temperature C IP Inlet Water Pressure 0 to 10 psi L Reservoir Level 1 Empty 5 Full VV Vent Valve 1 Open 0 Closed BV Bypass Valve 1 Open 0 Closed PWM P Circulating Pump Speed 0 Stop to 235 Full PWM M Mixing Pump Speed 0 Stop to 150 Full PWM H Heater Power 0 Off to 32 Full Power 6 1 2 Error Log and Operational Log The Model 2000 maintains two history logs The logs may be accessed while in Stop mode once Diagnostic Mode is activated by pressing the Down Arrow key The Error Log screens are labeled UD2 and the Operational Log screens are labeled UD3 The Operational Log contains a history of the last 16 alerts and recoverable alarms The Error Log contains a history of the last 8 non recoverable alarms Note that power failures do not generate a logged alarm Each screen provides information on the state of the Control Module when the event occurred including the current system hours Error Log Display Figure 6 3 31 The history logs are interpreted as follows Table 6 2 Log Definitions Field Definition Units or Range of Values
2. Chiller Capacity Test Model 2000 02 Water Temp lt 12 C Model 2000 03 or 10 Water Temp lt 13 C Blank Page 29 CHAPTER6 TROUBLESHOOTING 6 1 Diagnostic Mode The Model 2000 has a diagnostic mode which is designed to provide assistance with troubleshooting and provides access to the Calibration software To enter this mode power up the Control Module while holding the Automatic and Purge Mode keys located on the Remote Display The keys must be held for at least 5 seconds The LCD display will appear as shown below See Figures 6 1 and 6 2 after the normal power up screen sequence The control module will operate normally except these displays will replace the home display Caution Do not operate the device in Diagnostic Mode when the device is providing therapy to a patient unless closely monitored Access to screens is available through the Up and Down Arrow Keys The order of screens in the Diagnostic Mode while in Stop mode are as follows 1 Diagnostic Home Screens Standard Operation Screens UD1 System hours pump hours and system voltage setting 2 3 4 UD2 Operational Log 5 UDS Error Log 6 UD4 Calibration Procedure 30 6 1 1 Diagnostic Home Screens Toggle between these two diagnostic displays by pressing the Home key Diagnostic Home Page 1 Figure 6 1 Diagnostic Home Page 2 Figure 6 2 The display fields are Table 6 1 Display Field Definitions
3. Federal law USA restricts this device to sale by or on the order of a physician Medivance will not be responsible for patient safety or equipment performance if the procedures to operate maintain modify or service the Medivance Arctic Sun are other than those specified by Medivance This product should be serviced only by trained qualified personnel Use only distilled or sterile water The use of other fluids will damage the Arctic Sun System Any device connected to the RS232 data port must comply with the applicable IEC standard for that device When the system is powered off all changes will revert to the default unless the new settings have been established as new defaults Users should not use cleaning or decontamination methods different from those recommended by the manufacturer without first checking with the manufacturer that the proposed methods will not damage the equipment His advisable not to cancel the alarm or alert until the situation is resolved If an alarm is cancelled and the condition has not been cleared the alarm will recur If an alert is cancelled and the alert condition has not been cleared the alert will not recur unless the Stop Mode is activated Do not operate the unit in a diagnostic mode while delivering therapy to a patient Blank Page CHAPTER 2 THEORY OF OPERATION 2 4 Introduction The Model 2000 was designed to control patient temperature with a high level of precision
4. TEMPERATURE MANAGEMENT SYSTEM Model 2000 Service Manual C Medivance CHAPTER INTRODUCTION escscccccesesctcchecceacectetsacetacesacecuacsaccescceacbenstiaceecaaesdndeabcesadeaaecdanesstaececasstes 1 1 1 Use of the Model 2000 Service Manual sse nnne 1 1 2 Customer Information and Technical Support 1 1 9 System Description i nere EE 1 1 4 Symbols and Standards dne da Anal dn nn 3 1 5 Environmental 4 1 07 General Warnings ate eno ee enden Dn 4 127 A A 5 CHAPTER2 THEORY OF OPERATION sieesiseeiseessnee nenne entr NEEN tnn nnne nnns 7 2 1 lhntroduction serene edie edet ENEE ee ee e tte eee 7 2 2 System Components iii 7 2 9 Hydraulic Syste M sssi 2 Lie eee aate 7 2 4 Electronic Control System iiaea he tet edi die tice eed 11 CHAPTER 3 INSTALLATION recrutent tre EEN ER 13 3 1 Installation of Cables and Accessories 14 3 27 Power Up System ioco Saee 15 3 3 Filling the Control 6 15 CHAPTER 4 17 4 1 Recommended Maintenance Schedule eene 17 4 2 Clean External 17 4 3 Adjust Remote Display 18 4 4 Inspect Connectors and Cables eene nnne 18 4 5 Clean the 19 4 6 Drain and Replace eet RR RR e ER HR 20 4 7 Calibration and Safety 21 CHAPTER5 CALIBRATION AND SAFETY CHECK eeeesesseeeese
5. Low Water Flow Low water flow and flow through one pad is different from other Restriction in one pad allows flow to preferentially shunt through other pad This causes significant efficiency loss Eliminate kinks in lines or replace low flow pad Pads not adhered completely Movement of pads relative to patient Pads drying out causing loss of adhesion Adhere or replace pads to assure full contact Small pads used on large patient Improper size selection reduces surface area available for transfer Use largest pads that can fit on patient Assure pads are not overlapped in back Poor water temperature control but flow appears to be good Main Tank is overfilled Drain 0 5 liter water from the upper drain port Power up in User Diagnostic Mode and check the level Repeat this process until the level is less than 5 Poor water temperature control Main Tank is not full Heater or chiller circuit fault See Water does not heat or Water does not cool Pads connected Water does not heat to target temperature in Manual Mode Flow rate less than 800 ml min Heater does not provide full power at low flow rates See Low Water Flow CTU connected Water does not heat to target temperature in Manual Mode Power up in User Diagnostic Mode Enter Manual Mode with a water target of 42 C After stabilizing for several minutes note whether the display
6. Open the snap ring with a small screwdriver and pull the tube off the reservoir Reach through the right side of the chassis and slide the lever up to unlock the fitting from the flow pump Remove the fitting Unscrew the bracket screws on the left side of the control unit chassis with a 5 32 hex key and remove the heater assembly and the bracket through the opening After re assembly of the unit it is recommended to perform a Dielectric Withstand Hipot Chassis Test per Section 7 23 7 18 Chiller Power Relay Tools and Supplies Required 5 16 nut driver Remove the rear panel per Section 7 3 Note the position of each wire and remove all connections from the relay Remove the nut on the top and on the bottom of the relay with a 5 16 nut driver Remove the relay Reverse the process to replace the relay with a new one After re assembly of the unit it is recommended to perform a Dielectric Withstand Hipot Chassis Test per Section 7 23 70 7 19 Chiller Control Relay Tools and Supplies Required 1 4 nut driver 1 Remove the rear panel per Section 7 3 2 Note the position of each wire and remove all connections from the relay 3 Remove the standoffs on the top and on the bottom of the relay with a 74 nut driver 4 Remove the relay 5 After re assembly of the unit it is recommended to perform a Dielectric Withstand Hipot Chassis Test per Section 7 23 7 20 Inlet Outlet Manifold Too
7. half second tone conditions such as a momentary occlusion air cool every 10 seconds bolus hot restart or no load condition If the Alarm Alert indicator alarm is recurrent use the CTU to check the flashing calibration of the Control Module Calibrate if Alarm necessary If the alarm persists call Medivance Service 38 Water temperature Water temperature is Changes to Stop Operate the unit in User Diagnostic Mode and below safety level Allow system to warm Alarm below above 3 0 C 37 4 F Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing Manual Mode with the CTU attached at a setpoint of 4 C Observe T1 T2 T3 and T4 for at least 10 minutes after reaching stability If T4 drops below 3 C for more than a few seconds check the connector at J5 of the I O Card Verify that it is plugged in securely the wires emanating from it are intact and that the other end of the wires entering the solid state relay are intact Repeat the test Replace cables or the relay if necessary and retest If the error persists call Medivance Service 49 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 40 System unable to In Manual Mode Changes to Stop Use the CTU to check the calibration the Control maintain stable system is unable to Mode Audio alarm Modul
8. 24 and U 26 2 Place the new chip with the odd number extension number after the dash into 24 3 Place the new chip with the even number extension into U 26 Software Chip Location Figure 7 18 Monitor Software Chips 1 Using the extractor tool remove the chip from U11 2 Install the new chip Programmable Logic Device 1 Using the extractor tool remove the chip from U 21 2 Install the new chip 7 13 Handle 1 Unscrew the knobs on both sides of the handle 2 Replace with a new handle 67 U11 7 14 Py w qu ce Circulating Pump Tools and Supplies Required 5 32 hex key Remove the rear panel per Section 7 3 Remove the left side panel per Section 7 4 Drain the control unit per Section 7 1 Locate the cable that comes from the pump and unplug from the Input Output circuit card Note Observe the routing of the wire harness for the installation 7 15 Aog m of the new pump assembly With a 5 32 hex key remove the 2 screws on the side panel that hold the bracket of the pump The two screws are located toward the rear of the unit Disconnect the tube from the pump by pushing the lever on the pump up Remove the tube fitting Repeat the process for the tube fitting in the back of the pump At this point the pump assembly can be removed from the chassis Mixing Pump Tools and Supplies Required 5 32 hex key Remove front grill per Section 7 2 Remove rear panel per Section
9. 7 3 Remove the side panels per Section 7 4 Disconnect the cable that comes from the pump to the Input Output Circuit Card see Section 7 10 Note Observe the routing of the wire harness for installation of the new pump assembly 5 Remove the two screws that hold the pump bracket using a 5 32 hex key located to the front of the unit Push the lever up on the pump ports to disconnect the tube fitting Repeat the process for the tube fitting on the back of the pump At this point the mixing pump can get removed from the chassis 68 E Ri Circulating Pump Location Figure 7 19 Circulating Pump Mounting Screws Figure 7 20 Mixing Pump Mounting Screws Figure 7 21 Mixing Pump Mounting Screws Figure 7 22 7 16 Chiller Pump Tools and Supplies Required 10 11 12 harness Blade screwdriver Fe 5 32 hex key Remove the rear panel per Section 7 3 Remove the right side panel per Section 7 4 Disconnect the chiller harness at the connector located directly above the chiller pump assembly Grad Remove the insulation from around the tubing on the bottom of the chiller reservoir With a screwdriver loosen the hose clamp ring around the tubing Pull the tubing off from under the tank Chiller Pump Harness Location Remove the two screws on the metal frame that hold the Figure 7 23 bracket of the chiller pump assembly with a 5 32 hex key Remove the insulation from around the tube attac
10. Allow them to dry if necessary and retest Refer to Operator resistance half second tone If the error persists call Medivance Service Manual every 10 seconds Alarm Alert indicator Alarm flashing 75 Non recoverable T3 Thermistor signal Changes to Stop Check the connector at J9 pin 1 and J9 pin 7 of System error out of range high Mode Audio alarm the I O Card Verify that it is plugged in securely Refer to Operator resistance half second tone the wires emanating from it are intact and that the Manual every 10 seconds other end of the wires entering the sensor body is Alarm Alert indicator intact Power up and allow the Control Module to Alarm flashing run for 10 minutes If the error persists call Medivance Service 76 Non recoverable T3 Thermistor signal Changes to Stop Ensure that the I O Card or J9 pin 1 and J9 pin 7 system error out of range low Mode Audio alarm connector on it are not wet Allow them to dry if Refer to Operator resistance half second tone necessary and retest If the error persists call Manual every 10 seconds Medivance Service Alarm Alert indicator Alarm flashing 77 Non recoverable T4 Thermistor signal Changes to Stop Check the connector at J10 of the I O Card Verify system error out of range high Mode Audio alarm that it is plugged in securely the wires emanating Refer to Operator resistance half second tone from it are intact and that the other end of the wires Manual every 10 seconds e
11. Ensure that the rubber washers are installed on the temperature sensors of the new harness Observe the labeling on the cable to identify the temperature sensors Install T4 into the chilled water reservoir located toward the front of the control module 10 Install T1 in the bottom corner of the mixing reservoir 11 Install T2 in the bottom center of the mixing reservoir 12 Cover the temperature sensors with the provided insulation Note Don t bend the wires too sharply while applying the insulation 13 If the temperature sensor harness is replaced calibrate per Chapter 5 72 Sensor Locations tank insulation not shown for clarity Figure 7 26 7 22 Level Sensor Harness Be D gt 10 11 Tools required 7 16 nut driver 7 16 open end wrench 3 32 hexkey Silicone RTV Adhesive Drain the control module per Section 7 1 Remove the front grill per Section 7 2 Remove the rear panel per Section 7 3 Remove the left side panel per Section 7 4 Note Observe the routing of the Level Sensor Harness Remove the Input Output Manifold for access per Section 7 20 Pull the block toward you until it disengages from the chassis but do not remove connectors or lines With a 7 16 wrench hold the tank insert in place so it does not rotate This can be done through the opening of the left side of the control module Remove the screw and terminal with a 3 32 hex key from the tank insert Re
12. F and the flashing system is unable to heat in Automatic Mode 24 Patient Temperature Patient Temperature Current Mode Adjust Patient High Temperature Alert in the 2 below user defined 2 reading is equal or continues Audio custom menu if desired limit less than the user alarm half second defined value tone every 2 established in the minutes Alarm Alert Alert custom settings indicator flashing menu 25 System is warming Patient Temperature Current Mode Operate the system in Manual Mode with a setpoint and Patient 2 reading is above continues Audio below 38 C until the water temperature is less than Temperature 2 high 38 0 C 100 4 F alarm half second 38 C Ifthe error persists see General and water tone every 2 Troubleshooting Will Not Cool temperature is above minutes Alarm Alert Alert 38 0 C 100 4 F indicator flashing and the system is unable to cool in Manual Mode 26 System is cooling Patient Temperature Current Mode Operate the system in Manual Mode with a setpoint and Patient 2 reading is below continues Audio above 32 C until the water temperature is greater Temperature 2 low 32 C 89 6 F and alarm half second than 32 C If the error persists see General water temperature is tone every 2 Troubleshooting Will Not Heat below 32 0 C minutes Alarm Alert Alert 89 6 F and the indicator flashing system is unable to heat in Manual Mode 27 Patient Temperature Patient Temperature Chan
13. If the alarm persists call Medivance Service Note The calibration process can be aborted and restarted at any time by pressing Enter 6 Power up while holding the Automatic and Purge Keys 7 At the User Diagnostic Home Screen press the Up Key once twice if Patient Temperature 2 is enabled to scroll to the UD4 Screen Press the Enter Key to initiate the Test and Calibration Mode 8 Follow the prompts on the Remote Display Module Note The Control Module software will ask for the CTU calibration data termed A through G at various points in the process This data is printed on the CTU label 25 CTU Connections Figure 5 2 Medivance Calibration Test Unit REF 741 00 115 46 60Hz 4 5A is Colorado USA 8007 Dg a M ENT Ltd Arundel House 1 Liverpool Tr CA CTU Switch 1 Figure 5 3 CTU Switches 2 and 3 Figure 5 4 CTU S N 7001 A 10 88 B 25 55 C 34 54 D 39 99 E 0 02 F 0 07 CTU Calibration Data Figure 5 5 5 2 2 Stage 4 Temperature Out Calibration 1 Press the Enter Key if calibration is desired The sequence may be aborted at this stage if only verification is desired The Calibrate System menu screen displays the number of Cal Hours that have elapsed since the system was last calibrated 5 2 3 Stage 5 Acceptance 1s Save the calibration data if desired by pressing Enter on the Save Calibration Values screen If only verification
14. Mode for 5 Water leaking under Replace the leaking component minutes with pads connected positive pressure will Place the pads on the floor indicate the exact leak and then place the system in site Stop Mode Dry all water from the pads lines and manifold then place them on the floor Wait 5 minutes check carefully for water leaking from the pads lines or valves Pads connected Check the pads for folds or Pads folded or creased Smooth out and reapply pad to buckles created during foam to foam will remove buckles or creases Low water flow The pump placement reduce flow can be heard significantly CTU connected Power up in User Diagnostic If the pressure cannot Debris may be cleared by running tow wateriow Tow Mode Enter Manual Mode be maintained the flow the pump a full speed To ue with a water target of 28 C is low or the PWM is attempt to dislodge debris pressure or high PWM After stabilizing for several greater than 175 there replace the CTU with a fluid The pump can be heard minutes note whether the may be an external or delivery line and connect two display indicates internal leak or debris shunt tubes to the fluid delivery e 2550 lt FL flow lt is caught in a pump line manifold Enter Manual 3150 valve causing Mode The flow rate should inefficient pumping exceed 4 lpm for 5 minutes e P 6710 7 2 psi If Remove the shunts and value is less than 6 7 reconnect the CTU Repeat the then the system is unable che
15. by rapidly altering water temperature in response to a patient core temperature sensor using a closed loop algorithm To achieve rapid response with tight control the system is designed to circulate a minimum volume of water have a high heating and cooling capacity and include sensors for real time feedback of energy transfer 2 2 System Components The Model 2000 system is composed of several components Control Module The main unit which includes the hydraulics and major elements of the electronics Remote Display Module The primary control and monitoring interface for the user Fluid Delivery Line The reusable dual lumen tubing connecting the Control Module to the pads Interconnect Cables and Accessories The cables that connect the Control Module to mains power the Control Module to the Remote Display Module and optional patient temperature cables Accessories include fill tubes drain bags Fluid Delivery Line straps and others 2 3 Hydraulic System The hydraulic system within the Control Module consists of the following major elements Pumps Circulating pump Chiller pump Mixing pump Sensors 4 Water temperature sensors Flow meter Pressure sensor Valves Vent valve Bypass valve Fill valve Heater Tanks Circulating Tank Chiller Tank Main Tank nlet Outlet Manifold Chiller The hydraulic system is composed of two major fluid circuits the circulatin
16. designed and built to have a high degree of reliability however occasional failures do occur Use the trouble shooting methods in Chapter 6 or consult with Medivance Customer Service to determine the source component of the failure Once the source of the failure has been determined follow the appropriate procedure for replacement of the component Not all components can be replaced in the field A complete list of spare parts is available from Medivance Customer Service If a component fails that is not available as a spare part contact Medivance Customer Service In general reverse the order of removal to install a component Otherwise note any special instructions Caution Observe the electrostatic discharge control procedures ESD when working with any circuit card assembly 56 Fluid Reservoir d Latch Fill Line Port Inlet Outlet Manifold Mains Power Switch Chiller Control Relay Locations Mains Power Inlet Input Output Circuit Equipotential Stud Card Connections Heater Fuse Circulating Pump Card Cage Chiller Unit Chiller Heat Exchanger Reservoir Drain Port Chill Loop Drain Port Control Module Rear Inside View Figure 7 1 57 Circulating Pump Side Panel Keyholes Mixing Pump Chiller Pump Bracket Chiller Pump Chiller Pump Bracket behind fasteners Control Module Right Side Figure 7 2 58 Level Sensors 6 Heater Flowmeter Bracket fasteners Circulating Pump
17. half second tone 38 C Press Automatic and retest If the error water temperature is every 2 minutes persists see General Troubleshooting Will Not above 38 C Alarm indicator Cool Alarm 100 4 F and flashing System is unable to cool in Automatic Mode 09 Patient Temperature Patient Temperature Current Mode Adjust Patient High Temperature Alert in the 1 above user defined 1 reading is equal or Continues Audio custom menu if desired limit greater than the alarm half second user defined value tone every 2 established in the minutes Alarm Alert Alert custom settings indicator flashing menu 10 System cooling and Patient Temperature Changes to Stop Operate the system in Manual Mode with a setpoint Patient Temperature 1 reading is below Mode Audio alarm above 32 C until the water temperature is greater 1 low 32 0 C 89 6 F and half second tone than 32 C Press Automatic and retest If the water temperature is every 10 seconds error persists see General Troubleshooting Will below 32 0 C Alarm Alert indicator Not Heat Alarm 89 6 F and the flashing system is unable to heat in Automatic Mode 11 Patient Temperature Patient Temperature Current Mode Adjust Patient High Temperature Alert in the 1 below user defined 1 reading is equal or continues Audio custom menu if desired limit less than the user alarm half second defined value tone every 2 established in the minutes Alarm Alert Alert custom settings
18. hands at the top sides of the panel pull it straight out and away from the control module 3 To replace align the studs with the holes and push all four corners Front Grill Removal Figure 7 6 7 3 Rear Panel Tools and Supplies Required 5 32 hex key Turn off the power and unplug the power cord 2 Detach all cables and lines from the rear panel fluid delivery line fill line patient temperature cables remote display cable and strain relief 3 Remove the four mounting screws at the corners with the hex key from the rear panel 4 Pullthe panel off horizontally Rear Panel Removal Figure 7 7 61 7 4 Side Panels Tools and Supplies Required 5 32 hex key 1 Remove the rear panel per Section 7 3 Remove the front grill per Section 7 2 Remove the two screws located on the underside of one side panel with a 5 32 hex key 4 Hold the panel on both sides and move it towards the rear of the unit Slide the panel out from front to back There are four Side Panel Screw Removal key slots which accept white plastic key nuts Figure 7 8 5 Repeat this process for the other side panel 6 To replace the side panels align the white key nuts horizontally rotated to allow the threaded stud to engage the slots in the frame 7 5 Card Cage Tools and Supplies Required 5 64 hex key 5 16 nut driver Note Observe electrostatic discharge control procedures when handling circuit cards 1 Remov
19. important that the Model 2000 be properly maintained and serviced in accordance with the instructions described in this manual Only trained personnel should service this product 1 2 Customer Information and Technical Support Prior to using the Arctic Sun System a Medivance representative will provide on site in services to ensure adequate training has occurred Additional requests for technical support information or orders may be placed by mail fax or by calling Medivance Customer Service Medivance hours of operation are 8 am to 5 pm Mountain Standard Time Emergency support is offered after hours in the U S by calling 303 926 1917 or 877 267 2314 Other customers should contact their local distributor Additional educational materials such as training programs for in house staff operator manuals quick reference guides and a bibliography of relevant materials are available to all Medivance customers 1 3 System Description The Arctic Sun Temperature Management System is a thermoregulatory device that monitors and controls patient temperature within a range of 33 C to 37 C 91 4 F to 98 6 F The Arctic Sun System consists of the Model 2000 and disposable Arctic Sun Energy Transfer Pads The Model 2000 consists of the Control Module Remote Display Fluid Delivery Line cables and accessories With the Energy Transfer Pads adhered to the patient s skin the Model 2000 pulls temperature controlled water ranging between 4 C
20. indicator flashing menu 12 Patient and water Patient Temperature Current Mode Operate the system in Manual Mode with a setpoint temperature high Check water temperature Alert 1 reading is above 38 0 C 100 4 F and water temperature is above 38 0 C 100 4 F and the system is unable to cool in Manual Mode continues Audio alarm half second tone every 2 minutes Alarm Alert indicator flashing below 38 C until the water temperature is less than 38 C If the error persists see General Troubleshooting Will Not Cool 44 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 13 Patient and water Patient Temperature Current Mode Operate the system in Manual Mode with a setpoint temperature low 1 reading is below continues Audio above 32 C until the water temperature is greater Check water 32 C 89 6 F and alarm half second than 32 C If the error persists see General temperature outlet water tone every 2 Troubleshooting Will Not Heat temperature is below minutes Alarm Alert 32 0 C 89 6 F and indicator flashing Alert the system is unable to heat in Manual Mode 14 Patient Temperature Patient Temperature Changes to Stop Use the CTU to verify the accuracy of the Control 1 probe 1 reading is outside Mode Audio alarm Module Check connection of patient temperature di
21. is desired do not save If the new data is not saved the calibration will revert to the previous set of values Note If the Up arrow is pressed at this time a No Calibration Values were Saved prompt displays and pressing the Enter produces the Exit screen 5 2 4 Stage 6 Water Temperature Alarm Test 1 2 10 Press the Manual Mode Key Press the Down Key once and change the Water Target Temperature to 42 C Press the Home Key Allow the water temperature to stabilize at 42 C for at least 5 minutes Note It is important to allow the temperature to fully stabilize at 42 C If it does not it may not be possible to attain the alarm conditions Press the S4 switch on the CTU Monitor the T3 temperature and release the switch once the temperature reaches 44 5 C Start the timer when the T1 temperature reaches 43 01 C Verify that Alarm 37 sounds in less than 18 seconds Note If the T1 water temperature drops below 43 01 C restart the timer when the water again reaches 43 01 C Turn power off Turn power on and allow the Control Module to start normally Press the Manual Mode Key Press the Down Key once and change the Water Target Temperature to 42 C 26 11 12 13 Press the Home Key Allow the water temperature to stabilize at 42 C for at least 5 minutes Note It is important to allow the temperature to fully stabilize at 42 C If it does not it may not be possible to attain the
22. kinking Look for pad leaks by inspecting for a continuous stream of bubbles in the tubes exiting the pads when no air is entering Leak in pad Replace pad Enter Stop Mode then hold manifold above Control Module and pads pad connector side up Air fills the connectors Leak at seal between pad connector and the fluid delivery line manifold Air may be entering the return side of the fluid delivery line and is not visible in the pad lines Reseat the connector If leak continues replace fluid delivery line Disconnect each pad in turn from the manifold to determine whether one pad is contributing to the low flow Try to prevent air from entering the lines when removing the pads and run long enough to assure stability before checking the flow One pad is not functioning properly There is an air leak in the manifold Replace pad Replace fluid delivery line 34 Table 6 3 General Troubleshooting Guide Conditions Symptom Observation Cause Solution Pads connected Disconnect all pads from Fluid There is an external or Replace Fluid Delivery Line Delivery Line Enter Manual internal leak in the baw water lawor alr Mode The system does not system of fluid line continuously streaming remain in bypass mode for at This observation rules from pads The pump can least 3 minutes or Alert 1 out leaks in the pad be heard Occurs Run in Manual
23. lines kinked Reconnect the line onto the circulating pump Push the lever on the pump down to latch Reinstall the back panel Check the calibration according to Section 5 1 5 using a Calibration Test Unit Recalibrate if required 1 0 Manifold Connector Location Figure 7 35 77 Parameter APPENDIX A SPECIFICATIONS Specification Control Modes Automatic Manual Purge Stop Heater Capability 750 W Circulating Fluid Distilled or Sterile Water Reservoir Capacity 5 liters Water flow rate total 0 5 8 0 liter min Patient Probe Type YSI 400 Series compatible Number of Patient Probes 2 1 monitor controls alarms 1 monitor alarms Patient Temperature Display Range Resolution 10 C to 42 C 50 F to 107 6 F in 0 1 C F Patient Temperature Measurement Accuracy 0 4 C 10 C to 32 C 0 2 C 32 C to 38 C 0 4 C 38 C to 42 C includes 0 1 C external probe Patient Temperature Control Range Automatic Mode 33 C to 37 C 91 4 F to 98 6 F in 0 1 C F increments Water Temperature Display Range 3 C to 45 C 37 4 F to 113 0 F in 1 C F increments Water Temperature Control Range Manual Mode 4 C to 42 C 39 2 F to 107 6 F in 0 1 C F increments Maximum Water Temperature Automatic Mode 32 C to 42 C 89 6 F to 107 6 F in 1 C F increments Minimum Water Temperature Automatic Mod
24. storing 27 Table 5 1 Model 2000 Verification Data Test Criteria Flow Rate Factor H 300ml min 6 Flow lt Factor H 300ml min Inlet water pressure 7 2 psi P 6 8 psi Patient Temperature 1 PT1 4 checks 0 3 C lt CK1 lt 0 3 C 0 3 C lt CK2 lt 0 3 C 0 1 C lt CK3 lt 0 1 C 0 3 C lt CK4 lt 0 3 C Patient Temperature 2 PT2 4 checks 0 3 C lt CK1 lt 0 3 C 0 3 C lt CK2 lt 0 3 C 0 1 C lt CK3 lt 0 1 C 0 3 C lt CK4 lt 0 3 C Patient Temperature Echo Out 4 checks 0 2 C lt CK1 lt 0 2 C 0 2 C lt CK2 lt 0 2 C 0 2 C lt CK3 lt 0 2 C 0 2 C CK4 lt 0 2 C Water Temperature T1 3 checks 0 4 C lt CK1 lt 0 4 C 0 4 C lt CK2 lt 0 4 C 0 2 C CK3 0 2 C Water Temperature T2 3 checks 0 4 C lt CK1 lt 0 4 C 0 4 C lt CK2 lt 0 4 C 0 2 C lt CK3 lt 0 2 C Water Temperature T3 3 checks 0 4 C lt CK1 0 4 C 0 4 C CK2 0 4 C 0 4 C lt CK3 lt 0 4 C Water Temperature T4 3 checks 0 4 C lt CK1 lt 0 4 C 1 0 C lt CK2 lt 1 00 1 0 C lt CK3 lt 1 0 C Miscellaneous Heat Cool Flow Heat lt 120 seconds Cool lt 150 seconds Factor H 300ml min lt Flow lt Factor H 300ml min Secondary Alarm Alarm 37 in 18 seconds 28 Test Criteria Primary Alarm Alarm 34 in lt 14 seconds
25. thermal breaker mounted on the heater casing This breaker is not used for normal temperature control only to ensure that in the event of control failures the heater does not over heat CHAPTER3 INSTALLATION Bw e Fluid Reservoir Vent gt ds Handle Release Knob a Fluid Delivery Line Latch y WK Fluid Delivery Line Connection Cable Storage to Inlet Outlet Manifold El e Remote Display Cable US Panel Mounting Screw On Off Switch for Mains Data Collection RS 232 Power Reserved for Future Remote Display Connection Patient Temperature 1 Power Cord Mains Inlet Patient Temperature 2 Equipotential Stud Temperature Out Power Cord Storage Fluid Delivery Line Fill Line in Retainer Clip Serial Number Label Drain Ports Panel Mounting Screws Control Module Rear Figure 3 1 13 3 1 Installation of Cables and Accessories 1 Unpack the Model 2000 and accessories 2 Adjust the Control Module handle to a vertical position and secure by tightening the knobs on both sides 3 Connect the Remote Display Cable to the back of the Remote Display Install the Remote Display clamp onto the handle Route the cable through the three clips on the side of the handle Connect the Remote Display Cable connector at the labeled location on rear panel of the Control Module 4 Insert the Patient Temperature Cable into the labeled location on the rear panel of the Control Module 5 Insert the opt
26. 0 seconds and calibration error internal temperature continues Audio turn power back on If the error persists replace Restart system calibration from the alarm half second the Isolation Card and retest If the error persists Patient Temperature tone every 2 call Medivance Service Calibrate upon 1 probe input is not minutes Alarm Alert completion Alert functioning indicator flashing 19 Patient Temperature In Automatic Mode Changes to Stop Turn the Control Module off Wait 30 seconds and calibration error internal temperature Mode Audio alarm turn power back on If the error persists replace Restart system calibration from the half second tone the Isolation Card and retest If the error persists Patient Temperature every 10 seconds call Medivance Service Calibrate upon 1 probe input is not Alarm Alert indicator completion Alarm functioning flashing 20 Patient Temperature In Manual Mode Current Mode Turn the Control Module off Wait 30 seconds and calibration error internal temperature continues Audio turn power back on If the error persists replace Restart system calibration from the alarm half second the Isolation Card and retest If the error persists Patient Temperature tone every 2 call Medivance Service Calibrate upon 1 probe input is not minutes Alarm Alert completion Alert functioning indicator flashing 21 Patient Temperature Patient Temperature Changes to Stop Operate the system in Manua
27. 1 0 CCA does not illuminate during the purge Electronics fault Call Medivance Service Water spills from the Main Tank Vent in Manual or Automatic Modes Control Module has been switched into service during a case Overfilled tank due to pads being purged into a full Control Module Drain some water from the upper drain port Water jets from the Main Tank Vent in Purge Mode Control Module has been Switched into service during a case Overfilled tank due to pads being purged into a full Control Module Drain some water from the upper drain port Water jets from the Main Tank Vent in Fill Mode Cleaning Solution has not been added to the distilled water being used to fill the Control Module Low conductivity of the fluid Drain all water from the upper drain port Refill after adding Cleaning Solution to fluid being used to fill the Control Module Reservoir overfills Cleaning Solution has been added to the fluid being used to fill the Control Module Level sensor or cable fault Check the sensor connection at the I O Card Replace the level sensor harness Cleaning Solution has been added to the fluid being used to fill the Control Module Level sensor cable replacement unsuccessful Electronics fault Call Medivance Service Control Module will not fill At power up the level is read and indicates full The Control Module will not even attempt to fil
28. 62 7o Card Cage rh me a A an nn a lt ne nd 62 ZE Power Circ it Gard x nes arene Gani ee Aan Ati wee 64 Ls Power MOJU 64 7 8 Processor Circuit Card iii 65 7 9 Isolation Circuit Gard ccu ed t et etd tei deeds 65 7 10 Input Output Circuit Card Connections nnns 66 7 11 Input Output Circuit 66 LL Software CHIPS o aeter E vente atm tuns uter ete ei 67 7 13 Sblaligl8 rdi iae 67 7 14 Circulating PUMP erica 68 LADA Mixing PUmp uin icr ccce veinte aia 68 7416 Ghiller Pumps e eerte o et e om LM peers 69 PAT Oi en iiec 70 7 18 Chiller Power Relay o1 greet p mati att aed 70 7 19 Chiller Control Relay 2 ne e a ge Hd tete c E de ii 71 7 20 Inlet Outlet Manitold issues 71 7 21 Temperature Sensor 72 7 22 Level Sensor Harness erriari enit em heat n e ee Duden Medals 73 7 23 Dielectric Withstand Hipot Chassis Test 74 7 24 Dielectric Withstand Hipot Patient Applied Part Test 74 7 25 Inlet Outlet Manifold Valve Harness iii 76 CHAPTER1 INTRODUCTION 1 1 Use of the Model 2000 Service Manual The Arctic Sun Temperature Management System provides a safe and effective way of modifying patient temperature and delivering precise temperature control in a novel way This Service Manual provides a detailed description of the Model 2000 its construction routine maintenance and calibration The Model 2000 Operators Manual should be consulted for general operation detail It is
29. Bracket fasteners 59 Control Module Left Side Figure 7 3 Bracket fasteners The electronics are housed in the Electronics Card Cage and control all machine processes Five subassemblies comprise the electronics Power Module Power Inlet Equipotential Chassis Ground Stud Heater Fuse The Power Module converts AC to DC power and controls the heater The Power Card provides low voltage power for the electronics The Processor Card houses the microprocessors and peripherals The Isolation Card provides interfaces to the patient and external devices The I O Input Output Card interfaces to the internal sensors and actuators Power Card 150 44822 E Processor Card Isolation Card 500M 18 NOW Novi DZ 118 900M 12 1 2 3 3 Input Output Card Card Cage Circuit Card Identification Figure 7 4 60 7 1 Drain the Control Module Tools and Supplies Required Arctic Sun Drain Bag 1 Turn the Control Module off Caution Draining the system with power on may damage the chiller 2 Attach the two fittings on the bag to the two drain ports on the back of the control module The device will passively drain all tubing reservoirs and pumps within the system This is an adequate drain for maintenance procedures iiis Attached igure 7 5 7 2 Front Grill 1 Remove the front grill by first pulling the bottom out by reaching under the center of the bottom edge 2 Using both
30. C Error Code See Table 6 4 M Control Module Operating Mode 0 Initialization 12 Stop 2 Automatic 3 Manual 4 Purge 5 Fill P Patient Temperature 1 C OM Outlet Temperature Monitor T1 C O Outlet Temperature Control T2 C Inlet Temperature T3 C F Flow Rate ml min P Inlet Pressure 0 to 10 psi L Water Level 1 Empty 5 Full P Circulating Pump PWM 0 Stop to 235 Full C Mixing Pump PWM 0 Stop to 150 Full H Heater PWM 0 Off to 32 Full Power V Vent Valve State 1 Open 0 Closed B Bypass Valve State 1 Open 0 Closed Hr System Hours Hours 32 6 2 Card Cage Indicators and Test Points LEDs on the edges of the cards indicate the status of major functions and may be helpful in troubleshooting Figures 6 4 to 6 7 Access to the power supply voltages is also available at the card edge Note Use care in accessing these test points An insulated probe is needed to avoid shorting the test point to the frame Doing so will cause circuit board fuses to blow resulting in the need for component level repair NOT ACTIVE VGG VCC 24VU GND 24VU 24VS 24VS NOT ACTIVE TEST TEST LED TEST TEST TEST LED Power Card Figure 6 4 1 oo oo UI MON MON CTL CTL CONN BIT WDOG WDOGBIT Processor Card Figure 6 5 RS 232 1 RS 232 PAT PAT ECHO 2 TEMP TEMP 1 2 Isolation Card Figure 6 6 O O O O O O O FLOW GAS COOL FILL CHIL VV BV 1 0 Card Figure 6 7 6 3 General Troubleshoot
31. Control Module off Wait 30 seconds and System error start up Mode Audio alarm turn power back on If the error persists replace Refer to Operator synchronization fault half second tone the Processor Card If unsuccessful call Manual every 10 seconds Medivance Service Calibrate upon completion Alarm Alert indicator Alarm flashing 61 Non recoverable Control Processor Changes to Stop Turn the Control Module off Wait 30 seconds and system error parameter memory Mode Audio alarm turn power back on If the error persists replace Refer to Operator fault half second tone the Processor Card If unsuccessful call Manual every 10 seconds Medivance Service Calibrate upon completion Alarm Alert indicator Alarm flashing 62 Non recoverable Monitor Processor Changes to Stop Turn the Control Module off Wait 30 seconds and system error parameter memory Mode Audio alarm turn power back on If the error persists replace Refer to Operator fault half second tone the Processor Card If unsuccessful call Manual every 10 seconds Medivance Service Calibrate upon completion Alarm Alert indicator Alarm flashing 64 Non recoverable Unable to enable Changes to Stop Replace the Power Card and attempt to power up system error pump power Mode Audio alarm If the error persists call Medivance Service Refer to Operator Control half second tone Manual every 10 seconds Alarm Alert indicator Alarm flashing 65 Non recoverable Unable to enable Changes to S
32. Earth Ground 1 5 Environmental Conditions The Model 2000 should be stored and used in specific operating conditions Ambient Temperature Range Operating 6 10 C to 27 C 50 F to 80 F Note At higher room operating temperatures the units cooling capacity is compromised Storage 1115 30 C to 50 C 20 F to 120 F Note If the device is stored in a location where the temperature may fall below the freezing point the unit should be completely drained of water to prevent damage See Section 4 6 Ambient Humidity Range Operating atii ere Ted ipa dade 50 to 70 relative humidity non condensing Storag C 5 to 95 relative humidity non condensing 1 6 General Warnings Do not use the Arctic Sun in the presence of flammable agents because an explosion and or fire may result There is a risk of electrical shock and hazardous moving parts inside the machine Care should be exercised by service personnel and attention should be particularly paid to areas highlighted with warning symbols North America only Power cord has a hospital grade plug Grounding reliability can only be achieved when connected to an equivalent receptacle marked hospital use or hospital grade 4 1 7 Cautions See Operator s Manual for complete list of Cautions prior to using the Arctic Sun Temperature Management System to treat a patient This is not an exhaustive list and is not intended to replace the Operator s Manual
33. alarm conditions Press the S4 switch on the CTU Monitor the User Interface Water temperature and start the timer once the temperature reaches 42 6 Verify that alarm 34 sounds in less than 14 seconds Release the switch immediately Note If the water temperature drops below 42 6 C restart the timer when the water again reaches 42 6 C Note If the water temperature exceeds 44 1 C for more than 1 second Alarm 33 will occur and the test must be repeated Note If S4 is held too long or is pressed when no water is flowing a safety circuit will turn off power to the heater The CTU must be allowed to cool completely if this should occur 5 2 5 Stage 7 Chiller Capacity Test 1 2 Press the Manual Mode Key Press the Down Key once and change the Water Target Temperature to 6 C Press the Home Key Allow the water temperature to stabilize at 6 C for at least 5 minutes Press and hold S4 for 10 minutes Note the temperature of the water Release the switch Note If S4 is held too long or is pressed when no water is flowing a safety circuit will turn off power to the heater The CTU must be allowed to cool completely if this should occur Once verification and calibration is complete press the Purge key to remove the water from the CTU Turn off the Arctic Sun Model 2000 and remove the CTU Disconnect associated cabling from the Model 2000 and reconnect operator cabling Drain the water from the CTU before
34. ance Kit Caution Use only sterile or distilled water The use of other fluids will damage the system From Stop Mode press the down arrow until the fill screen appears Water Level Empty Enter to Fill Press Enter to proceed Note Pads cannot be attached to the Fluid Delivery Line during the fill process Follow directions on the display screen which read Place the Fill Tube in the container of water Press Enter to fill Press Enter again and the Model 2000 will automatically fill until the reservoir is full Blank Page CHAPTER4 MAINTENANCE 4 1 Recommended Maintenance Schedule Procedure Interval Clean External Surfaces As required Adjust Remote Display Clamp As required Inspect connectors and cables 3 months Clean the Condenser 3 months Replace Fluid 3 months Calibration and Operational Check Every 2000 hours or 250 uses which ever is less as indicated by system display 4 2 Clean External Surfaces Cleaning should include the exterior of the Control Module and the power cord Use a soft cloth and mild detergent or disinfectant according to hospital protocol The display screen can be wiped with a clean lint free moist cloth Fluid Delivery Lines and Temperature Cables should be cleansed with a hospital approved disinfectant 4 3 Adjust Remote Display Clamp Tools and Supplies Required 1 2 hex key The Remote Display clamp tension may need adjusting over ti
35. and 42 C 39 2 F and 107 6 F through the pads This results in heat exchange between the water and the patient Unlike conventional water based Systems this system operates under negative pressure relative to ambient Any break or leak in the fluid path will result in air entering the circuit instead of water leaking out The system functions in either an Automatic Mode or Manual Mode In Automatic Mode a patient temperature probe connected to the Control Module provides feedback to an internal control algorithm The temperature of the water increases or decreases automatically to achieve a pre Set patient target temperature determined by the clinician In Manual Mode the feedback control algorithm is not activated The operator adjusts the temperature of the water delivered to the pads directly and is responsible for monitoring patient temperature Model No Arctic Sun Temperature Management System Model 2000 Phone Toll free in the U S 877 267 2314 or 303 926 1917 FAX dun 303 926 1924 Address 321 South Taylor Avenue Suite 200 Louisville CO USA 80027 E mail customerservice medivance com Internet www medivance com European Representative Bard Limited Forest House Brighton Road Crawley West Sussex UK RH 11 9BP 0050 1 4 Symbols and Standards The Model 2000 bears the following symbols affixed to the system Ai C an Certified v A STERILE DISTILLED Ta
36. ar n amp o J10 Thermistors 402479 00 J8 Level Sensors 402476 00 J5 Chiller Hot Gas Bypass Control 402475 00 Input Output Circuit Card Connections Figure 7 16 Input Output Circuit Card Tools and Supplies Required 1 16 hex key Observe electrostatic discharge control procedures when handling circuit cards 1 Remove the rear panel per Section 7 3 2 Carefully disconnect all connectors from the Input Output circuit card releasing each locking tab before pulling 3 Remove the Input Output circuit card by removing the allen head screw with a 1 16 hex key and carefully prying outward at the top with a flat head screw driver Carefully pull outward until the circuit card is removed 4 Ifthe Input Output circuit card is replaced calibrate per Chapter 5 66 J2 Flowmeter 402470 00 J4 Mixing Purp 402471 00 J6 Flow Pump 402471 00 J7 Card Cage Fan 402481 00 J9 1 0 Harness 402391 00 Input Output Circuit Card Figure 7 17 7 12 Software Chips Tools required PLCC extractor Note Observe electrostatic discharge control procedures when handling circuit cards 1 Remove the rear panel per Section 7 3 2 Remove the Processor circuit card per Section 7 8 Note The software upgrade is performed by replacing the firmware chips Handle the chips as little as possible to avoid static damage Control Software Chips 1 Using the extractor tool remove the chips from U
37. ble 1 1 Model 2000 Symbols For the safe and effective use of this device the operator must consult the accompanying documents prior to use This symbol adjacent to the patient connections means that the thermal probe connection is a Defibrillator Proof Type BF Applied Part per standard IEC 60601 1 and affords the degree of patient protection defined in that standard for this type of applied part Models of the Arctic Sun that bear the Entela US C Monogram have been Certified for Safety by Entela Inc against standards C22 2 No 601 1 and UL 2601 Identifies the equipotential terminal on the equipment which is intended to be connected with the equipotential terminal s on one or more other types of equipment in close proximity in order to bring all pieces of equipment to the same potential for safety purposes Indicates high temperature part or component Indicates that only sterile or distilled water should be used when filling the Arctic Sun Control Module Identifies Patient Temperature 1 the primary patient temperature probe input Identifies Patient Temperature 2 the secondary patient temperature probe input Identifies the drain port Identifies the heater fuse Table 1 1 Model 2000 Symbols continued 50 C Identifies the storage temperature range 30 C 2 Ss Identifies the storage relative humidity range Indicates electrical hazard Indicates sharp object or a moving part Indicates
38. ck of pump PWM to generate full negative pressure e Circulating Pump PWM is greater than 200 indicating pump is running faster than normal to maintain flow and pressure No leak is found Operate the The pump head may Replace the Circulating Pump system as above Circulating be ineffective due to Pump PWM is high debris stuck in the pump CTU connected No leak is found Operate the Flowmeter fault Replace the Heater Flowmeter OW E system as above No flow is assembly e indicated in User Diagnostic pressure or high PWM Mode although some water The pump can be heard appears to be flowing CTU connected Check the Circulating Pump Pump connection fault Reseat the connector Allow the connection at the I O Card card to dry if necessary e Verify that the circuit card is pressure or high PWM not wet 35 Table 6 3 General Troubleshooting Guide Conditions Symptom Observation Cause Solution The pump cannot be heard Swap the Circulating Pump and Mixing pump connections on the I O Card Attempt to operate the system Mixing pump does not run Pump electronics failure Replace the Circulating Pump Pressure is more negative than 8PSI for more than a minute Pressure sensor or cable fault Replace the I O Manifold Assembly Pads connected Poor temperature control of patient Low water flow or air leaving pads Air leak in pads or lines See
39. e 4 C to 32 C 39 2 F to 89 6 F in 1 C F increments Mains Input 115VAC 60 Hz 11 A nominal 230VAC 50 Hz 5 5 A nominal Current Leakage lt 300uA Circuit Breaker 12 Amp Mains supply voltage fluctuations are not to exceed 10 of nominal supply voltage Parameter Specification Relative humidity range operating 5 70 Relative humidity range storage 5 95 Temperature range operating 10 C to 27 C 50 F to 80 F Temperature range storage 30 C to 50 C 20 F to 120 F Height of unit handle down 66 0cm 26 Length of unit 48 3cm 19 Width of unit 31 8cm 12 5 Weight of unit filled 52 7kg 116 lbs 79 APPENDIX B SHIPPING Due to the size and weight of the Model 2000 Control Module it should be shipped on a pallet using Medivance provided packaging materials If the original packaging is not available a shipping kit may be ordered from Medivance 1 Drain the control module per Section 4 7 Note the additional steps to completely drain the unit in order to prevent damage from freezing 2 Place the Control Module on the foam support which is mounted to the pallet Figure B 1 3 Cover the unit with the plastic bag Figure B 2 4 Place the cardboard tube over the top of the unit so the edges are outside the wood strips attached to the pallet 5 Place the molded foam insert on top on the unit 6 Place the cardboard cap on top of t
40. e Calibrate if necessary If the error water temperature control water within half second tone persists call Medivance Service 1 0 C F of set point every 10 seconds after 25 minutes in Alarm Alert indicator Alarm current mode or at flashing the time of last change in Water Target Temperature 41 Low bypass flow Insufficient internal Current Mode Use the CTU to check the calibration of the Control Heating not flow during priming Continues Audio Module Calibrate if necessary If the error available or bypass mode alarm half second persists call Medivance Service tone every 2 minutes Alarm Alert Alert indicator flashing 43 User settings not Saved customer Current Mode Turn the Control Module off Wait 30 seconds and saved System user profile settings Continues Audio turn power back on If the error persists replace default settings are invalid alarm half second the Processor Card If unsuccessful call restored tone every 2 Medivance Service Calibrate upon completion minutes Alarm Alert indicator flashing Alert 44 Invalid system log In Diagnostic Mode Current Mode Turn the Control Module off Wait 30 seconds and entry Service one or more entries Continues Audio turn power back on If the error persists replace information may be in the internal alarm half second the Processor Card If unsuccessful call corrupt system event log are tone every 2 Medivance Service Calibrate upon completion invalid Used by a min
41. e circulating water In addition draining is required for replacement of some components or prior to shipment or storage 1 Power off the system Caution Draining the system with power on may damage the chiller 2 Attach the two fittings on the bag to the two drain ports on the back of the control module The device will passively drain all tubing reservoirs and pumps within the system This is an adequate drain for maintenance procedures 3 Proceed with a complete drain for shipping or storage when freezing is a risk 3 1 Perform the partial drain procedure in step 2 3 2 Allow the control module to stand for 15 minutes to allow the chiller to return to room temperature 3 3 Power on the system The Level Empty alarm should occur and the chiller should not run Cancel the alarm If the chiler runs do not continue and power down immediately Drain the system again as in step 2 and power up again 3 4 From the main screen press the Down key three times to enter the Fill Mode Press enter Do not place the fill tube in water 3 5 With the Drain Bag still attached press enter to start a fill cycle which will empty the Circulating Pump 3 6 Press and hold the Down key for a minimum of 20 seconds to empty the internal Mixing Pump 3 7 Press the Stop key then power off the system Remove the Drain Bag and empty it 4 Fill Control Module per Section 3 3 prior to returning to use 20 A f Drain Bag Attached Fi
42. e the rear panel per Section 7 3 2 Remove right side panel Section 7 4 3 Through the right side of the frame disconnect the wire which connects to the rear of the card cage 4 Disconnect the heater cable from under the card cage Chiller Power Wire Harness Figure 7 9 Heater Wire Harness Figure 7 10 62 Disconnect all cables on the Input Output circuit card on the right side of the card cage per Section 7 10 Remove the two screws on the right side of the chassis left of the card cage with a 5 64 hex key Remove the two nuts in the back of the Input Output circuit card on the right side on the top and bottom with a 5 16 nut driver Lift out the card cage After re assembly of the unit it is recommended to perform a Dielectric Withstand Hipot Chassis Test per Section 7 23 63 Card Cage Mounting Screws Figure 7 11 Card Cage Mounting Nuts Figure 7 12 7 6 Power Circuit Card Tools and Supplies Required 1 16 hex key Note The machine does not have to be drained in order to complete this procedure Note Observe electrostatic discharge control procedures when handling circuit cards Remove the rear panel per Section 7 3 2 Remove the Power Circuit Card second from left by removing the bottom allen head screw with a 1 16 allen wrench and carefully prying the bracket at the top with a flat head screw driver 3 Carefully slide the circuit card out of the card cage until
43. ee Figure 7 34 If necessary place a blade screwdriver into the slot at the top Label of the stem to hold it secure while loosening the nuts ae Remove the solenoid coils from the stems Note the location of each and the associated label on the wire The 3 wires are labeled FV BV and PV The new solenoid coils will have to be returned to their proper location Removing Solenoid Nuts Figure 7 33 With a 7 16 wrench loosen the temperature probe and remove it from the manifold block Unplug the manifold harness from the Input Output Circuit Card by first compressing the tab on the top of the plug Do Valve not stress the wires It may be necessary to unplug the Stem three closest connectors to gain access The tabs on these Vake connectors must be compressed in the same manner to Washer release them Replace the harness Install the new temperature probe into the manifold replacing the orange rubber washer Tighten the probe until finger tight then tighten Ye turn Replace valve washers then each solenoid assuring the proper location of each see Figure 7 33 above Tighten the Removing Temperature Probe nuts onto the valve stems assuring the solenoid covers are Figure 7 34 properly aligned with the valve washers Reconnect the harness to the I O board with the connector tab oriented down Assure the connector is fully engaged Replace the manifold in the frame assuring the wires do not become pinched or the
44. eeenen nnne rca 22 5 1 The Calibration and Test UNI ss 22 5 1 1 Basic CTU Operation e dite tisane alerte etx ee dua aee de eene eus 22 A Un EE 22 5 1 3 Electrical une CET 22 5 1 4 ET wu Ile 23 5 1 5 Calibration edel Ee 23 5 1 6 Environmental Requirements essen nennen eene 24 5 2 The Test and Calibration Procedure ssssssssssseseeeeneeneeeenn nnne 24 5 2 1 Stage 1 2 and 3 Warm up Flow Check Patient Temperature Calibration Water Temperature Calibration and Interim Results Heporting 25 5 2 2 Stage 4 Temperature Out Calibration nennrennrenneen nsen nnn 26 5 2 3 Stage 5 ACCeptarice eec te ein dite Dee ig el deca 26 TABLE OF CONTENTS REF 000742 01 Rev K 5 2 4 Stage 6 Water Temperature Alarm Test 26 5 2 5 Stage 7 Chiller Capacity Test 27 CHAPTER 6 TROUBLESHOOTING nn nnnrrrsrsrsnneennnnneenennenneneennenenneneeneeneneneennenennenennes ge le ele EE EE 20 6 1 1 Diagnostic Home Screens eene nnn enne 31 6 1 2 Error Log and Operational Log ss 31 6 2 Card Cage Indicators and Test Points ssssssssssssseeee enne 33 6 3 General Troubleshooting Guide eene 34 6 4 Troubleshooting Alarms and Alerts AA 42 CHAPTER 7 COMPONENT REPLACEMENT s cccssecssseecesseeeeseeesesesesseeseseeeeeseeesseeseseanenseeeeeees 7 1 Drain the Control Module is 61 4 2 Front EU 61 1 93 Rear Patel ea tuetur eet veu 61 LI SIMS Panels esse
45. er Module Control Module is noisy The noise is present at all times and emanates from the bottom of the card cage A cooling fan may be failing Replace the Card Cage Circuit cards need not be replaced The noise is present at all times and emanates from the lower frame chiller area The chiller fan may be failing Call Medivance Service 40 Table 6 3 General Troubleshooting Guide Conditions Symptom Observation Cause Solution The noise occurs only when water is flowing The Circulating Pump may have air trapped in the pump head Debris may be cleared by running the pump a full speed Connect two shunt tubes to the fluid delivery line manifold Enter Manual Mode The flow rate should exceed 4 Ipm for 5 minutes If the pump is still noisy call Medivance Service The noise occurs only when water is flowing High flow flush is unsuccessful The Circulating Pump may be failing Replace Circulating Pump The noise occurs only during a control mode when the temperature is being regulated at the target The noise seems to burst on and off The Mixing Pump may be failing Replace the Mixing Pump Control Module will not power up When turned on the Control Module beeps possibly flashes the displays and goes silent beeps again and continues Electronics fault Call Medivance Service When turned on a fan can be heard b
46. fault Test the input with a cable and probe proven good on another Control Alarm Module If the Control Module proves inaccurate replace the Isolation Card and retest If the error persists call Medivance Service Calibrate upon completion 29 Patient Temperature In Automatic Mode Current Mode Turn the Control Module off Wait 30 seconds and 2 calibration error internal temperature continues Audio turn power back on If the error persists replace Restart system calibration from the alarm half second the Isolation Card and retest If the error persists Patient Temperature tone every 2 call Medivance Service Calibrate upon 2 probe input is not minutes Alarm Alert completion Alert functioning indicator flashing 30 Patient Temperature In Manual Mode Current Mode Turn the Control Module off Wait 30 seconds and 2 calibration error internal temperature continues Audio turn power back on If the error persists replace Restart system calibration from the alarm half second the Isolation Card and retest If the error persists Patient Temperature tone every 2 call Medivance Service Calibrate upon 2 probe input is not minutes Alarm Alert completion Alert functioning indicator flashing 31 Patient Temperature In Automatic Mode Current Mode Turn the Control Module off Wait 30 seconds and 2 calibration error internal temperature continues Audio turn power back on If the error persists replace Restart system calibration fr
47. fy system error out of range high Mode Audio alarm that it is plugged in securely the wires emanating Refer to Operator resistance half second tone from it are intact and that the other end of the wires Manual every 10 seconds entering the sensor body is intact Power up and Alarm Alert indicator allow the Control Module to run for 10 minutes If Alarm flashing the error persists call Medivance Service 72 Non recoverable 12 Thermistor signal Changes to Stop Ensure that the I O Card or J10 connector on it are system error out of range low Mode Audio alarm not wet Allow them to dry if necessary and retest Refer to Operator resistance half second tone If the error persists call Medivance Service Manual every 10 seconds Alarm Alert indicator Alarm flashing 73 Non recoverable T1 Thermistor signal Changes to Stop Check the connector at J10 of the I O Card Verify system error out of range high Mode Audio alarm that it is plugged in securely the wires emanating Refer to Operator resistance half second tone from it are intact and that the other end of the wires Manual every 10 seconds entering the sensor body is intact Power up and Alarm Alert indicator allow the Control Module to run for 10 minutes If Alarm flashing the error persists call Medivance Service 74 Non recoverable T1 Thermistor signal Changes to Stop Ensure that the I O Card or J10 connector on it are system error out of range low Mode Audio alarm not wet
48. g circuit and the chiller circuit see Figure 2 1 The circulating circuit controls the flow of water to the pads The chiller circuit provides a constant source of cold water that is pumped as needed into the circulating circuit Water in the circulating circuit is pulled from the Circulating Tank through the Inlet Outlet Manifold and out to the Energy Transfer Pads Water then returns from the pads through the Inlet Outlet Manifold to the negative pressure side of the positive displacement Circulating Pump Water leaves the Circulating Pump under positive pressure then passes through a turbine flow meter and heater before returning to the Circulating Tank Water in the Main Tank replenishes the circulating circuit The chiller circuit operates independent of the circulating circuit Water in the Chiller Tank drains into the centrifugal Chiller Pump where it then is pumped under positive pressure through the Chillers evaporator The evaporator is a heat exchanger with cold refrigerant on one side and water on the other Water then returns to the Chiller Tank to complete the cycle The system controls the temperature of the water in the Chiller Tank to 4 C by activating a valve on the refrigerant side when additional cooling is no longer needed When the system determines water must be warmed the heater is activated in the circulating circuit When the system determines water must be cooled water is drawn out of the Circulating Tank by the pos
49. ges to Stop Use the CTU to verify the accuracy of the Control 2 probe disconnected or out of range Alarm 2 reading is outside the lower limits of the display range in Automatic Mode Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing Module Check connection of patient temperature probe and cable If wet replace cable Check temperature cable connection at the rear of the Control Module Flex the cable to ensure that there is not an intermittent fault Test the input with a cable and probe proven good on another Control Module If the Control Module proves inaccurate replace the Isolation Card and retest If the error persists call Medivance Service Calibrate upon completion 47 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 28 Temperature probe Patient Temperature Changes to Stop Use the CTU to verify the accuracy of the Control 2 malfunction 2 reading is outside Mode Audio alarm Module Check connection of patient temperature Replace the upper limits of half second tone probe and cable If wet replace cable Check temperature probe the display range in every 10 seconds temperature cable connection at the rear of the or cable Automatic Mode Alarm Alert indicator Control Module Flex the cable to ensure that there flashing is not an intermittent
50. gure 4 6 4 7 Calibration and Safety Check See Chapter 5 for the complete procedure for calibration and safety check 21 CHAPTER 5 CALIBRATION AND SAFETY CHECK 5 1 The Calibration and Test Unit The Model 2000 Calibration and Test Unit CTU is an instrument that is used to calibrate the Model 2000 Control Module It is a hand sized unit that connects directly to the fluid delivery line port taking the place of the Model 2000 fluid delivery lines and pads 5 1 1 Basic CTU Operation The CTU is used as an external stimulus and measuring device by software embedded in the Control Module The CTU contains precision resistors a sensor for measuring water temperature and water heaters that are calibrated at the factory The factory calibration data is listed on the CTU and is entered into the Control Module during the calibration process The resistors simulate several patient temperatures After a warm up period the simulated temperatures are first applied to the patient temperature inputs to temporarily calibrate each channel This calibration is temporary in the sense that it is used to perform the balance of the testing It is not saved by the Control Module until the operator accepts it Once the patient temperature channel s accuracy has been established the Temperature Out circuit and the CTU s temperature sensor are connected to the Control Module s Patient Temperature inputs in turn The Control Module then circulates water through
51. hat there indicator flashing is not an intermittent fault Test the input with a Alert cable and probe proven good on another Control Module If the Control Module proves inaccurate replace the Isolation Card and retest If the error persists call Medivance Service Recalibrate upon completion 52 Extended period of Circulating water Remains in current Assess patient s skin Check to determine if water cold water delivery temperature has mode Audio circulating through the pads is at least 2 3 liters per Assess Patient been below alarms minute Determine whether the temperature probe 10 C 50 F for 8 of is placed properly Check to make sure the the previous 10 recommended number of pads is in use Determine Alert hours whether the patient requires additional sedation for shivering Assess whether environmental factors such as room temperature and hot lamps are interfering with the cooling process 53 Prolonged cold The Arctic Sun has Changes to Stop Assess patient s skin Assess whether the minimum exposure issued 11 alerts for Mode water temperature should be increased or whether extended periods of the temperature management therapy should be cold water delivery discontinued Alarm 51 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 60 Non recoverable Control and Monitor Changes to Stop Turn the
52. he tube 7 Band the cardboard tube and cap securely with at least two bands evenly spaced Figure B 3 and B 4 80 Foam on Pallet Figure B 1 Bagged Unit on Pallet Figure B 2 Packaged and Banded to Pallet Figure B 3 Packaged and Banded to Pallet Figure B 4
53. hed to the chiller pump which extends to the back of the pump in the lower part of the unit Loosen the hose clamp ring with a small screwdriver Pull the pump assembly off the tubing To replace insulate the pump head and the tubing with the adhesive coated foam insulation provided After re assembly of the unit it is recommended to perform a Dielectric Withstand Hipot Chassis Test per Section 7 23 69 7 17 Heater OV d qx qe 10 11 12 Tools and Supplies Required Blade screwdriver 5 32 hex key Drain the control unit per Section 7 1 Remove front grill per Section 7 2 Remove rear panel per Section 7 3 Snap Ring Removal i Figure 7 24 Remove the side panels per Section 7 4 Disconnect the cable that comes from the heater and goes to the cable connection directly behind the circulating pump Disconnect the flowmeter cable that comes from the heater assembly and plugs into the Input Output circuit card see Section 7 10 Note Observe the routing of the cable to the Input Output circuit card Disconnect the tubing from the upper drain port Push the insulation back where the tubing meets the elbow fitting Open the snap ring with a small screwdriver and pull the tubing from the fitting Disconnect the tube from the bottom of the mixing reservoir The tube is located closest to the bottom of the outside of the chassis Pull back the insulation where the tube meets the reservoir
54. ic cleaning of the exterior surfaces none is required To clean the CTU spray a mild detergent solution onto a towel and wipe down the unit Do not submerge the unit in water If heater becomes inoperative return the CTU to Medivance for service An open fuse is indicative of a problem that requires immediate service 5 1 5 Calibration The CTU should be returned to the manufacturer for calibration every two years The date of last calibration is indicated by the international symbol for calibration an upside down solid black triangle v which can be found on the top of the CTU CTU S N 7001 A 10 88 25 55 34 54 39 99 0 02 0 07 0 14 i 2850 Calibration Date W 2007 06 Calibration Data CTU Calibration Data Figure 5 1 23 5 1 6 Environmental Requirements The Calibration Test Unit should be stored and used in specific operating conditions Ambient Temperature Range Operating 18 C to 24 C 65 F to 75 F Storage 30 C to 50 C 20 F to 120 F Ambient Humidity Range Operating 5 to 95 non condensing Note If the CTU is used at a room temperature outside of the specified operating range the test system s accuracy will be degraded 5 2 The Test and Calibration Procedure The entire test and calibration process takes approximately 75 minutes Operator assistance is required only in certain stages Stage 1 Warm up Flow Check and Patient Temperature Ca
55. indicates any rise in the water temperature T2 Water does not warm at all Heater fuse is open caused by fault in heater circuit Replace fuse and Heater Flowmeter assembly CTU connected Water does not heat to target temperature in Manual Mode Heater fuse is intact Power up in User Diagnostic Mode Enter Manual Mode with a water target of 42 C After stabilizing for several minutes note whether the display indicates any rise in the water temperature T2 Water does not warm at all Power Module fault Replace the Power Module 36 Table 6 3 General Troubleshooting Guide Conditions Symptom Observation Cause Solution Heater fuse is intact Power Module replacement was unsuccessful Power up in User Diagnostic Mode Enter Manual Mode with a water target of 42 C After stabilizing for several minutes note whether the display indicates any rise in the water temperature T2 Water does not warm at all Heater thermal breaker tripped caused by fault in heater control circuit Call Medivance Service Pads connected Water cools but is reported to be unable to cool effectively when used with a patient Remove plastic grille and examine the condenser Chiller condenser clogged with lint Clean condenser CTU connected Water does not cool to target temperature in Manual Mode Power up in User Diagnostic Mode Operate the system i
56. ing 04 Water reservoir level Reservoir level is Remains in Stop Fill Reservoir If the error persists see General below minimum Fill empty or below the Mode Troubleshooting Will Not Fill reservoir minimum to run the Audio alarm half system Alarm second tone every 10 seconds Alarm indicator flashing 05 Water reservoir level After pads are Changes to Stop If connected to pads purge pads Fill Reservoir If below minimum Fill purged reservoir is Mode Audio alarm the error persists see General Troubleshooting reservoir or purge empty or below half second tone Will Not Fill pads minimum required to every 10 seconds Alarm run the system Alarm indicator flashing 07 Purge not complete A significant amount Remains in Stop See General Troubleshooting Fails To Purge Pads may contain extra water Alert of water was still being returned from the pads at the end of the purge cycle Mode at end of purge Audio alarm half second tone every 2 minutes Alarm indicator flashing 43 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 08 System warming and Patient Temperature Changes to Stop Operate the system in Manual Mode with a setpoint Patient Temperature 1 reading is above Mode Audio alarm below 38 C until the water temperature is less than 1 high 38 C 100 4 F and
57. ing Guide The following is a list of potential issues and methods of resolution The suggestions for each issue are listed from most to least probable Therefore each step assumes the previous steps have been checked For component replacement instructions see Chapter 7 Note that this guide assumes that no special equipment such as the Medivance Calibration Test Unit is available If available the Calibration Test Unit is a powerful diagnostic tool and it should be used in association with the instruction in its manual Table 6 3 General Troubleshooting Guide Conditions Symptom Observation Cause Solution An alarm or alert not solved by recommendations in the Operator s See Section 6 4 Troubleshooting Alarms and Alerts Pads connected Low water flow or air continuously streaming from pads The pump can be heard The pads have been filled then purged and then refilled Trapped air bubbles may restrict flow temporarily Allow the flow to stabilize for over 20 minutes before rechecking the flow rate Air can be removed by lightly tapping on the pads The pad connectors are not fully seated in the fluid delivery line manifolds Air leak in fluid delivery line manifold connection Reseat connectors Pad lines are kinked or occluded at either the connector and pad ends Restriction in fluid lines Remove kinks Recommend use of fluid delivery line straps to keep lines from
58. ional Patient Temperature 2 Cable into the labeled location on the rear panel of the Control Module 6 Insert the optional Patient Temperature Out Cable into the labeled location on the rear panel of the Control Module 7 Using the clips and wing nuts from the Strain Relief Kit anchor the Remote Display Cable and Clamp Rear cables to the back panel View Figure 3 2 8 Move the latch of the fluid In Out Manifold to the left Connect the Fluid Delivery Line to the Inlet Outlet Manifold Move the latch on the manifold to the right to lock it in place 9 Gently push the fitting of the fill line into the fill port Secure the line to the rear panel as shown in the picture Strain Relief Figure 3 3 Fill Line Figure 3 4 14 3 2 Power Up System 1 3 3 Insert the power cord into the power inlet Using the clips and wing nuts from the Strain Relief Kit anchor the cord to the back panel Plug the power cord into the wall outlet Locate the switch on the rear panel and turn the power on After the software initializes an alarm will sound and the display will read Alarm 5 Water level below minimum Fill reservoir or purge pads Clear the alarm by pressing the alarm key The display reads Medivance Arctic Sun Temperature Management System Filling the Control Module Add one vial of Arctic Sun Cleaning Solution to 4 liters of sterile or distilled water The solution is contained in the Arctic Sun Mainten
59. ists replace calibration data in alarm half second the Processor Card If unsuccessful call non volatile memory tone every 2 Medivance Service Calibrate upon completion Alert invalid minutes Alarm Alert indicator flashing 50 Patient Temperature Patient temperature Current Mode Use the CTU to verify the accuracy of the Control 1 erratic Check discontinuity Continues Audio Module Check connection of patient temperature temperature probe Significant change in alarm half second probe and cable If wet replace cable Check patient temperature tone every 2 temperature cable connection at the rear of the reading for more minutes Alarm Alert Control Module Flex the cable to ensure that there Alert than 8 minutes indicator flashing is not an intermittent fault Test the input with a cable and probe proven good on another Control Module If the Control Module proves inaccurate replace the Isolation Card and retest If the error persists call Medivance Service Recalibrate upon completion 51 Patient Temperature Patient temperature Current Mode Use the CTU to verify the accuracy of the Control 1 below control less than 33 C when Continues Audio Module Check connection of patient temperature range Check Automatic mode alarm half second probe and cable If wet replace cable Check temperature probe entered tone every 2 temperature cable connection at the rear of the minutes Alarm Alert Control Module Flex the cable to ensure t
60. itive displacement Mixing Pump and metered into the Chiller Tank This causes water to overflow the Chiller Tank and refill the Circulating Tank with cold water where it mixes cooling the circulating water The flow of water to the pads is controlled by regulating the Circulating Pump speed using pressure sensor P1 The pressure is regulated to 7 psi This assures that the flow through each pad is maintained regardless of how many pads are connected Since water in the pads and lines is at a negative pressure relative to ambient any break causes air to enter the circuit instead of water leaking out where it may contaminate the patient This valuable feature can make troubleshooting leaks more difficult The temperature of the water going out to the pads is controlled using a temperature sensor T2 and monitored by a temperature sensor T1 Both sensors are located in the Circulating Tank Temperature sensor T3 measures the temperature of water returning from the pads The difference between outlet and inlet water temperature along with the flow rate provides the control algorithm real time feedback on the current heat load for optimal temperature regulation Temperature sensor T4 is used to regulate the cold water within the chiller circuit There are three valves installed in the Inlet Outlet manifold to permit filling the system with water pre conditioning the water to a desired temperature and emptying the pads of water at the end of aca
61. k the I O Manifold connector at the I O Card Replace the I O Manifold assembly if necessary Recalibrate upon completion At power up the level is read and indicates less than full Upon initiation of fill one or no clicks are heard The Control Module tries to fill the pump can be heard but no water is ingested Only one or neither of the BV and FILL LEDs on the I O Card illuminate Electronics fault Call Medivance Service No patient temperature is displayed even though a probe is installed The probe and cable have not been tested on another Control Module An open circuit exists in either the probe or cable Replace the probe and cable in turn or try each on another Control Module to determine which is at fault Flex the cable and probe particularly near connections to determine whether there is an intermittent connection The probe and cable have been shown to work on another Control Module Electronics fault Call Medivance Service A patient temperature is displayed but no probe is installed At power up no alarm occurs The patient temperature channel is out of calibration Calibrate the Control Module At power up no alarm occurs Recalibration unsuccessful Electronics fault Call Medivance Service The Control Module is noisy The noise is present at all times and emanates from the Power Module A cooling fan is failing Replace the Pow
62. l Attempting to drain the tank yields little or no water Note the tank can hold about 2 8 liters The resistance between the GND TEST point on the Power Card and the chassis is greater than 1 ohm Low voltage circuitry ground fault Replace the Power Module Indicates full when tested as above ground resistance low Electronics fault Call Medivance Service Control Module will not fill At power up the level is read and indicates less than full Upon initiation of fill two clicks are heard The Control Module tries to fill the pump can be heard but no water is ingested Pads are connected to the patient lines preventing suction from being applied to the fill tube Disconnect all pads 39 Table 6 3 General Troubleshooting Guide Conditions Symptom Observation Cause Solution At power up the level is read and indicates less than full Upon initiation of fill two clicks are heard The Control Module tries to fill the pump can be heard but no water is ingested Pads not connected Vacuum leak in a patient line manifold valve See Low Water Flow At power up the level is read and indicates less than full Upon initiation of fill one or no clicks are heard The Control Module tries to fill the pump can be heard but no water is ingested Both the BV and FILL LEDs on the I O Card illuminate Bypass or Fill Valve fault Chec
63. l Mode with a setpoint 2 high Check 2 reading is above Mode Audio alarm below 38 C until the water temperature is less than patient temperature 38 C 100 4 F and half second tone 38 C Press Automatic and retest If the error water temperature is every 2 minutes persists see General Troubleshooting Will Not above 38 C Alarm indicator Cool Alarm 100 4 F and flashing System is unable to cool in Automatic Mode 22 Patient Temperature Patient Temperature Current Mode Adjust Patient High Temperature Alert in the 2 above user defined limit Alert 2 reading is equal or greater than the user defined value established in the custom settings menu Continues Audio alarm half second tone every 2 minutes Alarm Alert indicator flashing custom menu if desired 46 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 23 Patient Temperature Patient Temperature Changes to Stop Operate the system in Manual Mode with a setpoint 2 low Check patient 2 reading is below Mode Audio alarm above 32 C until the water temperature is greater temperature 32 0 C 89 6 F and half second tone than 32 C Press Automatic and retest If the water temperature is every 10 seconds error persists see General Troubleshooting Will below 32 0 C Alarm Alert indicator Not Heat Alarm 89 6
64. le The Monitor Changes to Stop Replace the I O Card and attempt to power up If system error Processor has failed Mode Audio alarm the error persists call Medivance Service Refer to Operator to detect a simulated half second tone Calibrate upon completion Manual water temperature every 10 seconds fault Alarm Alert indicator Alarm flashing 82 Non recoverable A D converter fault Changes to Stop Turn the Control Module off Wait 30 seconds and system error Mode Audio alarm turn power back on If the error persists replace Refer to Operator half second tone the Processor Card If unsuccessful call Manual every 10 seconds Medivance Service Calibrate upon completion Alarm Alert indicator Alarm flashing 83 Non recoverable The Monitor Changes to Stop Turn the Control Module off Wait 30 seconds and system error Processor does not Mode Audio alarm turn power back on If the error persists replace Refer to Operator communicate half second tone the Processor Card If unsuccessful call Manual every 10 seconds Medivance Service Calibrate upon completion Alarm Alert indicator Alarm flashing 84 Non recoverable The Control Changes to Stop Turn the Control Module off Wait 30 seconds and system error Processor does not Mode Audio alarm turn power back on If the error persists replace Refer to Operator communicate half second tone the Processor Card If unsuccessful call Manual every 10 seconds Medivance Service Calibrate upon completio
65. libration 10 minutes after a 10 minute warm up operator assistance required Stage 2 Water Temperature Calibration 30 minutes automatic Stage 3 Interim Results Reporting 1 minute operator assistance required Stage 4 Temperature Out Calibration 30 minutes automatic Stage 5 Acceptance 1 minute operator assistance required Stage 6 Water Temperature Alarm Test 15 minutes operator assistance required Stage 7 Chiller Capacity Test 15 minutes operator assistance required 24 5 2 1 Stage 1 2 and 3 Warm up Flow Check Patient Temperature Calibration Water Temperature Calibration and Interim Results Reporting 1 Replace the fluid delivery lines with CTU 2 Connect the Blue circular connector labeled PT1 to the Model 2000 connector Patient Temperature 1 larger thermometer and patient symbol 3 Connect the Blue circular connector labeled PT2 to the Model 2000 connector Patient Temperature 2 smaller thermometer and patient symbol 4 Connect the Black circular connector labeled TO to the Model 2000 connector labeled TEMP OUT 5 Set the CTU switches Gi B S2A s SZA Note For best results act promptly when instructed by the machine Do not allow the machine to lie idle waiting for data input or test unit switching Note If an alarm occurs during calibration check the CTU connections and switch positions If the alarm persists power down and start over
66. ls and Supplies Required 5 32 hex key 3 32 hex key 13 Remove the rear panel per Section 7 3 14 Note Observe the routing of the cable to the Input Output circuit card Ensure that wires are not pinched when reassembling 15 The Inlet Outlet Manifold is attached to the chassis by two shoulder screws inserted into keyholes Pull the Inlet Outlet manifold forward then down to slide it off the chassis Figure 7 25 Inlet Outlet Manifold 16 Remove the tubing and connectors from the bottom of the manifold by first removing the screws securing each connector using a 3 32 hex key 17 Unplug the manifold harness from the Input Output Circuit Card see Section 7 10 71 7 21 1 2 3 Temperature Sensor Harness Tools and Supplies Required 7 16 open end wrench 5 32 hex key Drain the control unit per Section 7 1 Remove the rear panel per Section 7 3 Remove the right side panel per Section 7 4 Note Observe the routing of the harness 4 Remove the Inlet Outlet manifold block for access Pull the block toward you until it disengages from the chassis Remove the harness from the cable clip located behind the manifold block Through the opening of the right side of the chassis remove the insulation from all three temperature sensors located on the bottom of the mixing and chilled water reservoirs Remove the temperature sensors from the reservoirs using a 7 16 open end wrench
67. me 1 Remove the Remote Display from the handle Disconnect the Remote Display Cable 2 Loosen the clamp knob until the bottom jaw swings clear of the top head Remove the black rubber plug in the top head by dida SE grabbing an edge and pulling straight out 19656 3 Using a 77 hex key adjust the hex bolt until proper tension is achieved Replace the plug and tighten the clamp knob Removing Rubber Plug Figure 4 2 Adjusting Tension Figure 4 3 4 4 Inspect Connectors and Cables Inspect all cables for breakage fraying excessive twisting or other signs of damage Replace damaged cables 18 4 5 Clean the Condenser The Arctic Sun condenser fins should be inspected for dirt and debris every three months or more often with heavy use or dusty environment The condenser is located underneath the grill on the front of the control module 1 Remove the front grill by pulling the bottom out then using both hands at the top of the panel pull it straight out and away from the control module For maximum performance the condenser fins should be free of dust and debris 2 Use a brush or vacuum to remove any dust or debris 19 Removing Front Grill Figure 4 4 Condenser Figure 4 5 4 6 Drain and Replace Fluid Tools and Supplies Required Arctic Sun Drain Bag It is recommended the Control Module be drained and refilled every 3 months to assure a satisfactory concentration of Cleaning Solution in th
68. move the remaining screws and terminals in the same fashion Note It might be necessary to remove the silicone sealant for the upper tank insert Install the new harness in the same manner following the color coding as in Figure 7 27 Note If a level sensor insert gets rotated rotate it back into the position where there is only a very slight compression on the rubber washer Seal the top level sensor insert with silicone RTV if it is removed or broken Route the harness back through the cable clip and plug it into the Input Output Circuit Card see Section 7 10 73 Blue Black Brown Red Orange Yellow Front of Tank Installation of Level Sensor Terminals Figure 7 27 Hold Insert While Tightening Screw Figure 7 28 7 23 Dielectric Withstand Hipot Chassis Test This test is to be performed in accordance with UL2601 1 EN60601 1 Section 20 4 which describes the application of voltage rising from no more than half the prescribed level to the peak over the course of ten seconds The voltage is maintained at that level for one minute and is then decreased over the course of ten seconds to less than half the peak A tester compliant with this standard should be used 1 Turn off the tester and the Control Module 2 Remove the Control Module power cord from Mains power and plug it into the tester outlet 3 Connect the tester ground lead to the equipotential stud on the Control Module located just below the p
69. n Alarm Alert indicator Alarm flashing 85 Non recoverable The model of the Changes to Stop Call Medivance Service system error Refer to Operator Manual Alarm Control Module could not be verified Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing 54 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 86 Non recoverable Power supply Changes to Stop Turn the Control Module off Wait 30 seconds and system error voltage out of range Mode Audio alarm turn power back on If the error persists replace Refer to Operator half second tone the Power Card and attempt a power up If the Manual every 10 seconds error persists call Medivance Service Calibrate Alarm Alert indicator upon completion Alarm flashing 98 x Non recoverable Processor fault Changes to Stop Replace the Processor and retest Calibrate upon system error Mode Audio alarm completion Refer to Operator half second tone Manual every 10 seconds Alarm Alert indicator Alarm flashing 99 Non recoverable Processor Fault Changes to Stop Replace the Processor Card Calibrate upon system error Refer to Operator Manual Alarm Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing completion 55 CHAPTER 7 COMPONENT REPLACEMENT The Model 2000 is
70. n Manual Mode with a water target of 4 C for 5 minutes No sound emanates from the chiller The CHILL LED on the I O Card is on Chiller Power Relay or cable fault Check the cables between the relay and the I O Card Also check the cables between the relay and the Power Module and chiller Replace cables and or the relay if necessary Power up in User Diagnostic Mode Operate the system in Manual Mode with a water target of 4 C for 5 minutes No sound emanates from the chiller The CHILL LED on the I O Card is off The reservoir level in the diagnostic display Lx is less than 2 Water reservoir level insufficient to run the chiller Fill reservoir If unsuccessful see Will Not Fill Power up in User Diagnostic Mode Operate the system in Manual Mode with a water target of 4 C for 5 minutes No sound emanates from the chiller The CHILL LED on the I O Card is off The reservoir level in the diagnostic display Lx is greater than 2 Electronics or chiller fault Call Medivance Service CTU connected Water does not cool to target temperature in Manual Mode Power up in User Diagnostic Mode Operate the system in Manual Mode with a water target of 4 C for 5 minutes The chiller runs but T4 remains at or above room temperature Chiller fault Call Medivance Service 37 Table 6 3 General Troubleshooting Guide Conditions Symptom Observation Cau
71. nds bolus hot restart or no load condition If the Alarm Alert indicator alarm is recurrent use the CTU to check the Alarm flashing calibration of the Control Module Calibrate if necessary If the alarm persists call Medivance Service 35 Water temperature Water temperature is Changes to Stop Operate the unit in User Diagnostic Mode and low Allow system to below 3 5 C Mode Audio alarm Manual Mode with the CTU attached at a setpoint warm 38 3 F half second tone of 4 C Observe T1 T2 T3 and T4 for at least 10 every 10 seconds minutes after reaching stability If T4 drops below Alarm Alert indicator 3 C for more than a few seconds check the Alarm flashing connector at J5 of the I O Card Verify that it is plugged in securely the wires emanating from it are intact and that the other end of the wires entering the solid state relay are intact Repeat the test Replace cables or the relay if necessary and retest If the error persists call Medivance Service 36 Water temperature Water temperature is Changes to Stop Call Medivance Service above safety level above 44 C Mode Audio alarm Allow system to 111 2 F half second tone cool every 10 seconds Alarm Alert indicator flashing Alarm 37 Water temperature Water temperature is Changes to Stop Allow the system to cool then press Automatic or above safety level above 43 C Mode Audio alarm Manual This alarm may be caused by transient Allow system to 109 4 F
72. ng circuit cards 1 Remove the rear panel per Section 7 3 2 Remove the Processor circuit card by removing the bottom hex head screw with a 1 16 hex key and carefully prying outward at the top with a flat head screw driver Carefully pull outward until the circuit card is removed 3 If the Processor circuit card is replaced calibrate per Chapter 5 7 9 Isolation Circuit Card Tools and Supplies Required 1 16 hex key Note Observe electrostatic discharge control procedures when handling circuit cards 1 Remove the rear panel per Section 7 3 2 Remove the Isolation circuit card by removing the bottom allenhead screw with a 1 16 allen wrench and carefully prying outward at the top slot with a flat head screw driver Then carefully pull outward until the circuit card is removed 3 If the Isolation circuit card is replaced calibrate per Chapter 5 After re assembly of the unit it is recommended to perform a Dielectric Withstand Hipot Patient Applied Part Test per EE Section 7 24 Isolation Circuit Card Figure 7 15 65 7 10 Input Output Circuit Card Connections 1 Many of the wiring harnesses connect to the Input Output circuit card In the course of troubleshooting or repair it may be necessary to remove some or all of the connections The following figure describes these connections 7 11 Note 2 e ke mm J T K ALES J3 Not Used ki Se Ji ais da
73. ntering the sensor body is intact Power up and Alarm Alert indicator allow the Control Module to run for 10 minutes If Alarm flashing the error persists call Medivance Service 78 Non recoverable T4 Thermistor signal Changes to Stop Ensure that the I O Card or J10 connector on it are system error Refer to Operator Manual Alarm out of range low resistance Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing not wet Allow them to dry if necessary and retest If the error persists call Medivance Service 53 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 79 Non recoverable T1 and T2 differ by Changes to Stop Turn the Control Module off Wait 30 seconds and system error more than 1 0 Mode Audio alarm turn power back on If the error persists call Refer to Operator degree C half second tone Medivance Service Manual every 10 seconds Alarm Alert indicator Alarm flashing 80 Non recoverable The Control Changes to Stop Replace the I O Card and attempt to power up If system error Processor has failed Mode Audio alarm the error persists call Medivance Service Refer to Operator to detect a simulated half second tone Calibrate upon completion Manual water temperature every 10 seconds fault Alarm Alert indicator Alarm flashing 81 Non recoverab
74. o be drawn into the pads and the circulating circuit emptying the pads The water level in the Main Tank is sensed by detecting conductivity with an array of stainless steel studs in the tank There are five level sensors and a reference sensor y ELLE LE LS Chiller Pump Chiller Circuit O nnnnnnunnun A lt a OA A Eeer Vent Line Inlet Outlet Manifold Circulating Pump Circulating Circuit Chiller Air Flow O Drain Ports Model 2000 Hydraulic Schematic 10 Figure 2 1 2 4 Electronic Control System The electronic control system consists of two independent subsystems the Control and the Monitor The Control Subsystem performs all of the normal machine operations while the Monitor Subsystem continually monitors important machine operations with independent sensors If the Control acts incorrectly with respect to the safety of the patient the monitor will disable pump power thus preventing inappropriate therapy from being delivered Each subsystem has a microprocessor watchdog keyboard input circuitry audio alarm outlet water temperature sensing circuitry and patient temperature sensing circuitry The Control Subsystem performs the following functions Command keyboard interpretation and information display Outlet water temperature control Water flow control Patient temperature measurement Patient Temperature 1 and control Temperature Out signal generation Cold
75. om the alarm half second the Isolation Card and retest If the error persists Patient Temperature tone every 2 call Medivance Service Calibrate upon 2 probe input is not minutes Alarm Alert completion Alert functioning indicator flashing 32 Patient temperature In Manual Mode Current Mode Turn the Control Module off Wait 30 seconds and 2 calibration error internal temperature continues Audio turn power back on If the error persists replace Restart system calibration from the alarm half second the Isolation Card and retest If the error persists Patient Temperature tone every 2 call Medivance Service Calibrate upon 2 probe input is not minutes Alarm Alert completion Alert functioning indicator flashing 33 Water temperature Water temperature is Changes to Stop Call Medivance Service high Allow system to cool Alarm above 44 0 C 111 2 F Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing 48 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 34 Water temperature Water temperature is Changes to Stop Allow the system to cool then press Automatic or high Allow system above 42 5 C Mode Audio alarm Manual This alarm may be caused by transient to cool 108 5 F half second tone conditions such as a momentary occlusion air every 10 seco
76. omprise the Isolation Card One island is connected to the Backplane and provides an interface to the rest of the card cage This island 11 is referenced to chassis ground The other islands are isolated from the Backplane island by opto isolators or transformers The RS 232 1 RS 232 2 and Temperature Out Echo islands are isolated from the Backplane and from each other to a breakdown voltage of at least 500V The patient temperature island is isolated from all others to a level of 1500V It should be noted that in addition to this the 24V power supply in the Power Module isolates all low voltage circuitry to a level of 4000V from Mains Input Output I O Circuit Card The I O Card contains the majority of the actuator and sensor circuitry T1 T2 T3 and T4 the flowmeter pressure sensor and level sensor are conditioned on the I O Card Both pump motors the valves and the refrigeration system are controlled by this circuit card The remaining circuitry is housed in the Remote Display Module This module communicates with the card cage via a cable having 13 twisted pairs using a technology called Low Voltage Differential Signaling LVDS which minimizes both the risk of spurious signals interfering with communication and the emission of electromagnetic energy The Remote Display Module houses LED display drivers keyboard interpretation circuitry an audible alarm primary and an LCD text module There is also a manually resettable
77. or sterile water to fill the system Pads connected System fails to purge completely Pads do not empty well during purge cycle A click is heard when the purge is initiated Vent line is kinked Inspect vent line which is small diameter line exiting the bottom of the Inlet Outlet Manifold and entering top of tank Replace if kinked Pads do not empty well during purge cycle A click is heard when the purge is initiated Water has inadvertently entered purge line or valve Repeat purge multiple times to attempt to clear water If necessary detach one end and drain Pads connected System fails to purge completely Pads do not empty well during purge cycle A click is heard when the purge is initiated Multiple purge cycles are unsuccessful Tank is overfilled Drain 0 5 liter water from the upper drain port Power up in User Diagnostic Mode and check the level Repeat this process until the level is less than 5 38 Table 6 3 General Troubleshooting Guide Conditions Symptom Observation Cause Solution Pads do not empty well during Purge valve Replace the I O Manifold purge cycle No click is inoperative assembly Recalibrate upon heard when the purge is initiated The VV LED on the UO CCA illuminates during the purge completion Pads unable to empty during purge cycle No click is heard when the purge is initiated The VV LED on the
78. ower inlet Turn on the Control Module power switch Turn on the tester Set the tester voltage to 1500VAC Stand clear of the Control Module and start the test Do not touch the Control Module while the test is in progress Verify that no alarm occurs gue Tester Ground Lead to Equipotential Stud Figure 7 29 7 24 Dielectric Withstand Hipot Patient Applied Part Test Call Medivance Service for instructions 74 blank page 75 7 25 Inlet Outlet Manifold Valve Harness Tools and Supplies Required 5 32 hex key 9 16 wrench 7 16 wrench 1 Remove the rear panel per Section 7 3 2 Note Observe the routing of the cable to the Input Output N 2 circuit card Ensure that wires are not pinched when Inlet Outlet Manifold reassembling Figure 7 30 3 Lift the lever on the Circulating Pump located below the manifold then remove the connector from the pump Removing Pump Port Figure 7 31 4 Pull the Inlet Outlet manifold forward then down to slide it off the chassis 5 Unplug the pressure transducer plug from the green circuit board by first compressing the tab on the underside of the connector Do not stress the wires Removing Plug Figure 7 32 76 10 11 12 13 14 15 Check that the valve stems are tight but do not over tighten Remove the nut from the top of each solenoid coil being careful not to unscrew the valve stem s
79. rol malfunction Replace temperature probe or cable Alarm 1 reading is outside the high limit of the display range in Automatic Mode shorted Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing Module Check connection of patient temperature probe and cable If wet replace cable Check temperature cable connection at the rear of the Control Module Flex the cable to ensure that there is not an intermittent fault Test the input with a cable and probe proven good on another Control Module If the Control Module proves inaccurate replace the Isolation Card and retest If the error persists call Medivance Service Calibrate upon completion 45 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 17 Patient Temperature In Automatic Mode Changes to Stop Turn the Control Module off Wait 30 seconds and calibration error internal temperature Mode Audio alarm turn power back on If the error persists replace Restart system calibration from half second tone the Isolation Card and retest If the error persists Patient Temperature every 10 seconds call Medivance Service Calibrate upon 1 probe input is not Alarm Alert indicator completion Alarm functioning flashing 18 Patient Temperature In Manual Mode Current Mode Turn the Control Module off Wait 3
80. sconnected or out the lower limits of the half second tone probe and cable If wet replace cable Check of range display range in every 10 seconds temperature cable connection at the rear of the Automatic Mode Alarm Alert indicator Control Module Flex the cable to ensure that there flashing is not an intermittent fault Test the input with a Alarm cable and probe proven good on another Control Module If the Control Module proves inaccurate replace the Isolation Card and retest If the error persists call Medivance Service Calibrate upon completion 15 Unable to obtain Patient temperature Changes to Stop Use the CTU to verify the accuracy of the Control stable patient discontinuity Mode Audio alarm Module Check connection of patient temperature temperature for Significant change in half second tone probe and cable If wet replace cable Check automatic control patient temperature every 10 seconds temperature cable connection at the rear of the reading for more Alarm Alert indicator Control Module Flex the cable to ensure that there than 10 minutes flashing is not an intermittent fault Test the input with a Alarm cable and probe proven good on another Control Module If the Control Module proves inaccurate replace the Isolation Card and retest If the error persists call Medivance Service Calibrate upon completion 16 Temperature probe 1 Patient Temperature Changes to Stop Use the CTU to verify the accuracy of the Cont
81. scription of alarm and alert codes and messages and the condition limits that triggered the alarm or alert Note This guide includes non recoverable alarms These alarms should be address only by someone trained and qualified to work on this system 42 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 01 Low fluid pressure in Fluid delivery line is Current Mode See General Troubleshooting Low Flow lines Check open to air leaking Continues Audio connections or has significant air alarm half second in line tone every 2 minutes Alarm Alert Alert indicator flashing 02 Low water flow to Flow to the pads is Current Mode See General Troubleshooting Low Flow pads decreased by gt 50 Continues Audio of the maximum flow alarm half second Check lines detected during the tone every 2 connections and case or since the last minutes Alarm Alert pads low flow alert or the indicator flashing flow is lt 0 3 liters per minute 300 Alert ml minute 03 Water reservoir level Reservoir fluid level Alert occurs after Fill Reservoir If the error persists see General low almost empty There Purge is complete at Troubleshooting is only enough water start up or after a fill left in the reservoir to cycle Alert run one procedure Audio alarm half second tone every 2 minutes Alarm Alert indicator flash
82. se Solution Power up in User Diagnostic Mode Operate the system in Manual Mode with a water target of 4 C for 5 minutes The cooling command PWM Mxx is nonzero and T4 stabilizes below 6C Pump cable or connection fault Check the Mixing Pump connection at the I O Card Verify that the circuit card is not wet Reseat the connector Allow the card to dry if necessary Power up in User Diagnostic Mode Operate the system in Manual Mode with a water target of 4 C for 5 minutes The cooling command PWM Mxx is nonzero and T4 stabilizes below 6C The Mixing Pump connection at the I O Card is dry and secure The pump head may be ineffective due to debris stuck in a valve or the pump electronics have failed Replace the Mixing Pump Power up in User Diagnostic Mode Operate the system in Manual Mode with a water target of 4 C for 5 minutes The cooling command is nonzero and T4 stabilizes below 6C Mixing Pump replacement ineffective Electronics fault Call Medivance Service Power up in User Diagnostic Mode Operate the system in Manual Mode with a water target of 4 C for 5 minutes the cooling command is nonzero and T4 changes little Electronics or chiller fault Call Medivance Service Water drained from system appears green Highly alkaline tap water used at some point to fill system Causes chelating of copper ion from chiller evaporator Drain and only use distilled
83. se When the Fill mode is activated water is drawn up through the Fill Tube through the Fill Valve FV by the Circulating pump The water then enters the Circulating Tank and by gravity passes to the Main Tank Air displaced by the water exits the Main Tank through a small hole in the top of the tank It is important to note that pads cannot be connected during this operation The user may wish to pre condition the temperature of the water prior to pads being connected The system will detect the absence of pads connected by feedback from the flow meter and pressure sensor and will open the Bypass Valve BV Water is drawn out of the Main Tank through the Bypass Line and is shunted past the Fluid Delivery Lines into the circulating circuit 8 where it returns back into the Circulating Tank Water flows through the leveling line from the Circulating Tank back into the Main Tank During this cycle the temperature of the water is controlled by activating the Heater or Mixing Pump Automatic activation of the Bypass Valve occurs briefly at the beginning of both Automatic Mode and Manual Mode in order to completely prime the Circulating Pump If pads are connected the Bypass Valve will close after one minute A user can initiate the Purge Mode in order to empty the pads of water prior to disconnecting them Purge Mode causes the Vent Valve VV to open to atmosphere through the vent line communicating with the top of the Main Tank This causes air t
84. the card protrudes approximately one inch to expose the Piezo Power Circuit Card Alarm and the DC Power cable connectors Disconnect the Figure 7 13 Piezo Alarm and DC Power cables 4 Carefully slide the Power circuit card approximately another inch and disconnect the AC Sync cable 5 Now the Power circuit card may be fully removed 6 After re assembly of the unit it is recommended to perform a Dielectric Withstand Hipot Chassis Test per Section 7 23 7 7 Power Module Tools and Supplies Required 1 16 hex key Note Observe electrostatic discharge control procedures when handling circuit cards 1 Remove the rear panel per Section 7 3 2 Remove the right side panel per Section 7 4 3 Remove the Power circuit card per Section 7 6 4 Disconnect the Chiller Power cable from the back of the card cage per Section 7 5 5 Disconnect the heater power cable at the bottom of the card cage per Section 7 5 6 Remove the Power Module by removing the 1 16 hex head Power Module screws at the top and bottom of the bracket and carefully pulling Figure 7 14 outward 7 After re assembly of the unit it is recommended to perform a Dielectric Withstand Hipot Chassis Test per Section 7 23 64 7 8 Processor Circuit Card Tools and Supplies Required 1 16 hex key Note The machine does not have to be drained in order to complete this procedure Note Observe electrostatic discharge control procedures when handli
85. the CTU at various temperatures In this way the patient temperature channel can then be used to check and calibrate the accuracy of the Control Module s internal water temperature sensors and circuits The fluid path in the CTU is designed to allow a specific flow rate at the operating pressure Since the Model 2000 controls the inlet pressure at a constant 7 psi a crosscheck of flow and pressure measurement accuracy can be obtained The inlet pressure offset is zeroed during the initial warm up period The CTU water heaters are used to slowly raise the system water temperature above its high temperature limits in order to verify correct operation of the Control Module s safety systems The test unit heaters are thermally and electrically protected and are only powered while pressing the Heater Power Switch 5 1 2 Warnings The CTU must not be used on equipment connected to a patient Do not use the Calibration and Test Unit in the presence of flammable agents because an explosion or fire may result Anyone performing the procedures must be appropriately qualified Carefully observe the Calibration and Test unit for fluid leaks before and during use Leakage may result in lower flow rates or an electrical shock hazard 5 1 3 Electrical Ratings Voltage 115V 60Hz or 230V 50Hz Current 4 5A or 2 25A Fuse 6 3A Slow Blow 2 Power 500W 22 5 1 4 Maintenance The CTU contains no serviceable parts Other than period
86. top Replace the Power Card and attempt to power up system error pump power Mode Audio alarm If the error persists call Medivance Service Refer to Operator Monitor half second tone Manual every 10 seconds Alarm Alert indicator Alarm flashing 66 Non recoverable Unable to disable Changes to Stop Replace the Power Card and attempt to power up system error pump power Mode Audio alarm If the error persists call Medivance Service Refer to Operator Control half second tone Manual every 10 seconds Alarm Alert indicator Alarm flashing 67 Non recoverable Unable to disable Changes to Stop Replace the Power Card and attempt to power up system error pump power Mode Audio alarm If the error persists call Medivance Service Refer to Operator Monitor half second tone Manual every 10 seconds Alarm Alert indicator Alarm flashing 70 Non recoverable Mains signal is Changes to Stop Replace the Power Card and attempt to power up system error Refer to Operator Manual Alarm missing or inconsistent Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing If the error persists call Medivance Service 52 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 71 Non recoverable 12 Thermistor signal Changes to Stop Check the connector at J10 of the I O Card Veri
87. ut no lights appear Power Card fault Replace the Power Card The Control Module has failed Biomed checkout Call Medivance Service 41 6 4 Troubleshooting Alarms and Alerts The Arctic Sun is designed with the patient s and operator s safety in mind The Control Module has redundant cross checking systems and a multitude of self tests It detects inappropriate conditions and notifies the user Many of these conditions can be addressed by clinical actions alone These are described in the Operator s Manual If the alarm or alert cannot be resolved clinically or is recurrent the matter should be addressed by technical personnel Table 6 4 below is intended as an aid in such an investigation Alerts and Alarms have specific definitions Alert Alerts are intended to inform the user about patient and equipment status without interrupting the procedure Alarm When an Alarm condition occurs there is a chance that a potentially unsafe condition has occurred or could occur with respect to the equipment the patient or an improperly functioning component Alarms are divided into two types recoverable and non recoverable Recoverable alarms may be cleared when a condition is met Non recoverable alarms require correcting the condition and powering the system back up to clear the alarm Non recoverable alarms are identified as such on the display Refer to the Alarm amp Alert Troubleshooting Table for a de
88. utes Alarm Alert designated clinical indicator flashing Alert engineering or Medivance service 46 Non recoverable User interface not Changes to Stop Check Remote Display Cable connections on the System error detected by control Mode Audio alarm remote display module and Control Module Refer to Operator System half second tone Ensure that they are secure Turn the Control Manual every 10 seconds Module off for 30 seconds and turn power back on Alarm Alert indicator If the error persists replace the Remote Display If flashing unsuccessful call Medivance Service Alarm 47 Non recoverable User interface not Changes to Stop Check Remote Display Cable connections on the system error Refer to Operator Manual Alarm detected by monitor system Mode Audio alarm half second tone every 10 seconds Alarm Alert indicator flashing remote display module and Control Module Ensure that they are secure Turn the Control Module off for 30 seconds and turn power back on If the error persists replace the Remote Display If unsuccessful call Medivance Service 50 Table 6 4 Alarm and Alert Troubleshooting Alarm Message Displayed Alarm Alert System Status Troubleshooting Alert Description 48 Patient temperature Patient Temperature Current Mode Turn the Control Module off Wait 30 seconds and out invalid Output Echo Continues Audio turn power back on If the error pers
89. water supply temperature control Valve control The Monitor Subsystem performs the following functions Redundant command keyboard interpretation Outlet water temperature monitoring Patient temperature measurement Patient Temperature 2 Pump power control Power supply monitoring Data logging output to the RS 232 port The majority of the hardware comprising the electronic control system is located within the card cage The card cage consists of six major elements See Figure 7 4 Power Module The Power Module includes a 24VDC medical universal input switching power supply IEC601 1 compliant a Mains circuit breaker cooling fan heater circuit fuse equipotential stud and solid state relay The Power Module is connected to the Power Card by two pigtail connectors Backplane The Backplane is passive serving only to connect the four circuit cards listed below Power Circuit Card The Power Card provides low voltage power regulation to the balance of the electronics as well as Mains line synchronization with 4000V isolation from Mains pump power control a Mains loss alarm and a secondary audible alarm The Mains loss circuit is powered by low leakage capacitors and needs no battery Processor Circuit Card The Processor Card houses the Control and Monitor microprocessors and their associated circuitry including nonvolatile memory for each Isolation Circuit Card Five isolated islands of circuitry c

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