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        Calibration/Test Unit (CTU) Operator`s Manual
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1.  CK3  lt  0 2  C       Water Temperature T3  3 checks      0 4  C  lt  CK1  lt  0 4  C   0 4  C  lt  CK2  lt  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 0  C   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  lt  18 seconds       Test    Criteria       Primary Alarm    Alarm 34 in  lt  14 seconds       Chiller Capacity Test       Model 2000 02   Water Temp   lt  12  C    Model 2000 03 or  10   Water Temp   lt  13  C       APPENDIX A SPECIFICATIONS    Voltage  115V  60Hz or 230  50 60Hz  Current  4 5A or 2 25A   e Fuse  6 3A Slow Blow  2    e Power  500W    Specifications  e Voltage  115V  60Hz ou 230  50 60Hz  e Courant  4 5A ou 2 25A  e Fusibles  6 3A  2   e Alimentation  500W    20    
2.  may result in  damage to the device     e The CTU must not be used on equipment while connected to a patient     e Do not use the Calibration and Test Unit in the presence of flammable agents because an  explosion or fire may result     e Anyone performing the procedures must be appropriately qualified     e 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  Discontinue use immediately if  leakage is observed     e For indoor use only     CHAPTER 2 THEORY OF OPERATION    21 Introduction    The Calibration and Test Unit  CTU  is an instrument that is used to calibrate and verify operation of  the ARCTIC SUN  Temperature Management System 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  The CTU can be used to semi automatically test and calibrate the Control  Module s two patient temperature measurement inputs  the temperature out function  and the internal  water temperature measurement channels  It can also be used to automatically verify the Control  Module s flow rate and inlet pressure measurements  Correct operation of the Model 2000 s primary  water over temperature alarm can also be verified manually using this device     2 2 Basic CTU Operation    The CTU is used as an external stimulus and measuring device by software embedded in the Cont
3.  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     2 3 Controls    A rotary switch  S1   two slide switches  S2 and S3   and a heater switch  S4  comprise the CTU  controls  The Output Select Switch  S1  is used to select the temperature simulator to be applied to  the patient temperature channel  Six switch positions represent specific temperatures as follows     e Position A is    open    or    no connection     e Position B is approximately 10 8   C  e Position C is approximately 25 5   C  e Position D is approximately 34 5   C  e Position E is approximately 40 0   C  e Position F is a    shorted    connection     The precise values of the simulators listed above are determined by a calibration process and are  listed on a calibration sticker on the CTU     The slide switch  S2  is used as follows     e Position A connects Patient Temperature Channel 1 to the rotary switch and Patient Temperature  Channel 2 to the Temperature Out Channel     e Position B connects Patient Temperature Channel 1 to the CTU temperature sensor and Patient  Temperature Channel 2 to the rotary switch     e Position C connects Patient Temperature Channel 1 to the Temperature Out Channel     The slide switch  S3  is used as follows     e Position A connects the internal thermistor to an    open    connection   e Position B connects the internal thermistor to a parallel r
4. Both T1 and T2 readings must be within 0 24   C of the probe  the  T3 sensor must be within 0 4  C of the probe reading  and the T4 sensor must be within 0  4  C    11     checked at the 6 deg temperature only   An    ck err X    message  X   sensor 1 2  3  or 4  is displayed  if the criteria is not met     2 5 8 Calibration   All checks  with the exception of the Temperature Out check  must have been successfully completed  before calibration is allowed  The Temperature Out check must at least be attempted  but does not  have to be successful  since the check will fail if the function has not been previously calibrated  N A  is displayed following the    Cal System     prompt if calibration is not allowed  At this point  the  operator may record the system clock and reject or proceed with the new calibration     The final stage of calibration uses PT1 to measure the Temperature Out as it is stepped through the  range of possible values  This process takes about 28 minutes  Upon completion  the operator is  prompted to save the calibration values     The information saved during the save process includes     e New cal factors generated during the calibration   e CTU values  A thru G  entered during the test  e Cal Hours value which was set to zero prior to the save     The stored CTU values can be manually set to defaults by exercising the    Erase Novram User  Defaults     Diag 23  menu option in advanced service mode  Additionally  stored CTU values will  automatically be s
5. Medivance     ARCTIC SUN   Temperature Management System    Calibration Test Unit   CTU   Operator s Manual      SA  A a ss  SHE SC    Sp  a BA  EE    Medivance     Calibration Test Unit    REF 741 00 115   46  60Hz 4 5A       CHAPTER 1 INTRODUCTION ses nanana n0NA KNA KNNANN SANA ANAN SUMA NN NN NN NN KANN ANAN KNAN KEE KEEN unene nenanem nanen aa 3  1 1 Use of the Calibration Test Unit  CTU  Operator s Manual 3  1 2 Customer Information and Technical Support    3   13 System  Descriptio Naa stihl eA E eee A                     3  1 4 Symbols and Standards            s eeeeeeneeene eeste ee eent nssn tetr nssnnsttnntnntnnstnnnsnnsstnssnnnntnnnnnsrnnsrnnnnn 5  1 5 Environmental Condions sir 6  1 6     General WathiNgS ET 6  CHAPTER 2 THEORY OF OPERATION    nnnencennenenerenneennennes 7  2 1    ugeet EE 7  2 2  Basic CU  OPO rations Sr                  ne tn a ast Ar Naa reine ia anne 7  2 3         EE 7  2 41 SGONNECLIONS ee  EE ee EEGENEN 8  2 5 Understanding the Test and Calibration Sequence                  naawa nnwwwananawannaananaaanaanwannnas 9  2 5 1 Calibration Factor 6  9  2 5 2 Screen Navigation    siennes 9  2 5 3 dl le 9  2 54 Pre Warm and Flow      9  2 5 5 Patient Temperature Channel Checks  namana awanaaanaaawanaawanannaaaanaasanwnann 10  2 5 6 Temperature Out Check    sisi 10  2 5 7 Water Temperature Check      2    mmnanwawanawawanaananaaanaaaaananananaaanasanasanaananaasnasansnasassnanana 11  2 5 8      CalilbratiOnits rente fo tat aca E 12  2 6 Water Tempe
6. Model 2000  that bear the ETL Monogram have been Certified for Safety by ETL Intertek in  accordance with standards C22 2  No  61010 1  ISA 82 02 01  IEC 61010 1  MOD   and UL 61010 1     Indicates high temperature part or component  The maximum temperature of  this internal component allowed by the protective system is also listed     Indicates electrical hazard     Indicates Earth Ground   Identifies the heater fuse     Identifies the storage temperature range     Identifies the storage relative humidity range     Indicates the date of manufacture    Indicates conformity with European standards for this device    Denotes calibration data     Denotes a push button  momentary switch     1 5 Environmental Conditions    e Ambient Temperature Range   o Operating Temperatures  18  C to 24  C  65  F to 75  F   o Transport and Storage Temperatures   30  C to 50  C   20  F to 120  F     e Ambient Humidity Range   o Operating Humidity  5  to 95  relative humidity  non condensing  o Transport and Storage Humidity  5  to 95  relative humidity  non condensing    e Ambient Atmospheric Pressure Range   o Operating  375 mmHg to 795 mm Hg  o Transport and Storage  375 mmHg to 795 mm Hg    NOTE  If the Calibration Test Unit is used at higher room temperatures  the test system   s  cooling capability and accuracy may be degraded     e Ingress Protection Rating IPXO0 for ordinary usage     1 6 General Warnings    e This equipment is to be used only as described in this manual  Failure to do so
7. R USE    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 Calibration  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     m Stage 6  Water Temperature Alarm Test  15 minutes  operator assistance  required      Stage 7  Chiller Capacity Test  15 minutes  operator assistance required    4 1 Stage 1  2  and 3  Warm up  Flow Check  Patient  Temperature Calibration  Water Temperature  Calibration  and Interim Results Reporting    ech    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       S1  B    S2  A  s S3  A    Note  For best results  act promptly when instructed by the  machine  Do not allow the machine to lie 
8. arted at any time during the test  The first time the check is aborted the sequence  restarts at the beginning of the current check  The second time the check is aborted the sequence  restarts at the beginning of the check group  Each check is completed when the following criteria is  met     e The difference between patient temperature average and the respective CTU temperature  value is within 0 8 C     e The patient temperature is stable within 0 01 C     If any check cannot meet the above criteria within 60 seconds  a message is displayed along with a  prompt to retry     Temporary calibration parameters are calculated based on the data obtained from Check 1  A  and  Check 4  D   These parameters are then applied to the average values obtained for all four checks   These values are then checked against the respective CTU values that had been entered  The  measured values must be within 0 14 C of the CTU values for successful completion  An error  message is displayed if the criteria is not met     The process is identical for Patient Temperature 2 with the exception of the S2 position     2 5 6 Temperature Out Check    The Temperature Out Check is very similar to the patient temperature checks in that the same four  sensor simulators are used  The operator is prompted to sequence the system through a PT1  measurement of each  while PT2 measures the Temperature Out   Temperature Out is an    echo    of  Patient Temperature 1   Obviously  this test requires precise measurem
9. ata  Figure 5 5    4 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     4 3 Stage 5  Acceptance    1     Save the calibration data  if desired  by pressing Enter on the     Save Calibration Values    screen  If only verification 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     4 4 Stage 6  Water Temperature Alarm Test    1   2     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 t
10. d Test Unit and ARCTIC SUN  Temperature Management System Model 2000  Control Module work together to perform the tests and calibration in a semi automated sequence   This section gives a step by step description of how this is accomplished    2 5 1 Calibration Factor Longevity    In order to perform this process accurately  various parameters of the Control Module must first be  calibrated to be used in subsequent measurements  It should be noted that this calibration is  temporary and it applys only during the Test and Calibration Sequence  This data is saved only if the  operator accepts the calibration at the end of the sequence     2 5 2 Screen Navigation    Screen navigation is achieved primarily through prompts and operator responses  Pressing the  Remote Display Enter Key will move the system through a defined test sequence  The Up and Down  Keys are also used for data entry and for scrolling through some menu selections  Other remaining  keys function normally  such as Automatic  Manual  Purge  Stop  and Cancel and do not change  function during this process  It should be noted  however  that the Control Module will abort the test  and calibration sequence and return to the User Diagnostic Mode screen if any of these keys are  pressed     2 5 3 Initiation    Test and Calibration Mode is a sub mode of User Diagnostic Mode  The test and calibration  sequence is started by scrolling to the UD4 Screen following the prompts  The Control Module will  enter Test and Calibra
11. e Management System and how the CTU can be used to troubleshoot  problems in addition to its normal test and calibration functions     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 30 am to 6 pm Eastern Time  Emergency support is offered after  hours by calling 887 267 2314     1 3 System Description    The CTU is  for the most part  a passive device that provides stimulus and feedback to the ARCTIC  Sun   Temperature Management System to enable it to test and calibrate itself  The sole active  function of the CTU is to provide an external heat source to force the circulating water temperature  over the safety limit of the machine in order to test its safety systems     Model No          ARCTIC 501 Temperature Management System Model 2000  Phone               Toll free 877 267 2314 Fax  720 880 5400  Address            321 South Taylor Avenue  Suite 200   Louisville  CO 80027  E mall               ARCTICSUNOrders crbard com    Internet  www  medivance com    European Representative     Bard Limited  Forest House  Brighton Road  Crawley  West Sussex UK  RH 11 9BP    1 4 Symbols and Standards    The CTU bears the following symbols affixed to the system     A       Table 1 1  CTU Symbols    For the safe and effective use of this device  the operator must consult the  accompanying documents prior to use     Models of the ARCTIC SUN    Temperature Management System 
12. e 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  Temperature Management System  Model 2000  and remove the CTU  Disconnect associated  cabling from the Model 2000 and reconnect operator cabling     Drain the water from the CTU before storing    Table 4 1  Model 2000 Verification Data       Test    Criteria       Flow Rate    Factor H   300ml min  lt   Flow  lt  Factor H    300ml min       Inlet water pressure     7 2 psi  lt  P  lt   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  lt  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  lt  CK3  lt  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 
13. ent by the patient  temperature channels  Therefore  the patient temperature checks must first be successfully    10    completed  If not   N A  is displayed at the Temperature Out Check summary screen to indicate that  it could not be completed     Each check is completed when the following criteria is met     e The difference between the PT1 average and the respective CTU temperature value is within  0 8  C     e The Temperature Out  as measured by PT2  is stable within 0 01   C    If any check cannot meet the those criteria within 75 seconds  an error message displayed along with  a prompt to retry     2 5 7 Water Temperature Check    The Water Temperature Check again requires that the operator enter calibration data from the CTU   E through G  Once this is done  the system requires the user change the S3 position at the beginning  of the low temperature set point and then back after the low temperature setpoint has completed   The system runs in Manual Mode for the duration of the test  As the system runs  the water  temperature is controlled at various setpoints while PT1 measures the temperature of the water  flowing through the CTU  This reference temperature is then used to check the system s internal  water temperature sensors  Check 2 and Check 4 also serve as heating and cooling capacity tests     Four segments of up to 15 minutes each comprise the Water Temperature Check  Check 1 takes  place at approximately 6  C  Check 2 at approximately 28  C  Check 3 at approx
14. esistance  shifting the temperature up at  the low water temperature setting  allowing it to be read by the patient temperature circuit   The heater power switch  S4  is a momentary  normally open switch that applies AC power to the two  250W heaters when pressed and held in the ON position     2 4 Connections    A hydraulic connection and three electrical connections must be made to the control module so that  the unit will function correctly in conjunction with the control module s software functions     e The hydraulic connection is a custom fitting which mates directly to the control module  The  seal must be tight with no leaks to ensure a proper test     e The three electrical connections are labeled    PT1        PT2     and    TO        o PT1 corresponds to the primary patient temperature receptacle on the control  module     o PT2 corresponds to the secondary patient temperature connector   o TOcorresponds to the temperature out connector on the control module     e TO has a different keying scheme from PT1 and PT2  and therefore cannot be interchanged   However  care must be taken when connecting PT1 and PT2 because they can be  interchanged  If this does occur  the control module will indicate an error on the user  interface display     e The electrical cables do not supply a voltage or current  They are passive connections with  the voltage or current being supplied by the control module     2 5 Understanding the Test and Calibration Sequence    The Calibration an
15. et  the system performs a purge for approximately one minute to  prepare for checking the inlet pressure offset  Then once purging is complete  the system performs  an internal test of the patient temperature channels  If successful  it indicates completion of the pre   warm   flow check and the final average flow is displayed along with a prompt to continue  If  successful completion of the pre warm   flow check does not occur within 12 minutes of its initiation  a  time out error is indicated  Also note that the pre warm   flow check can be aborted by pressing the  Enter Key  It can be started again at any time during the test sequence     At this point  operator assistance is needed to observe the flow result and to remove the CTU so that  the pressure sensor and circuit can be zeroed  The pressure offset is calculated after the user  responds and the pressure stabilizes within 0 01PSI  The pressure offset result is then displayed for  the user to observe  Note that if the offset is greater than  0 5PSI  a message is displayed     2 5 5 Patient Temperature Channel Checks    Operator assistance is needed to start the Patient Temperature 1  PT1  checks  Four items of CTU  calibration data must be entered  A through D  The operator is then prompted to sequence the  system through measurement of a set of precision resistors that simulate a patient temperature  sensor at various temperatures  Any of the temperature checks can be aborted by pressing the Enter  Key  and then rest
16. et to defaults if the cyclical redundancy check  crc  value for either of the CTU  values is incorrect when retrieved from memory     The default CTU values are     A 10 87   C  B  24 54   C  C  34 35   C  D  39 97   C  E  0 00   C  F  0 00   C  G  0 00   C    2 6 Water Temperature High Alarm Check   The CTU includes a 500W heater that is activated by a momentary switch  This heater can be used  to add heat when the Arctic Sun is operating at its highest water temperature setpoint to force a high  water temperature alarm  thus verifying the alarm s correct operation     CHAPTER 3 MAINTENANCE    3 1 Recommended Maintenance    The Calibration and Test Unit contains no operator maintainable parts  Other than periodic cleaning  of the exterior surfaces  none is required     Cleaning instructions  Spray a mild detergent solution onto a towel and wipe down the unit  Take  care to not saturate the towel with the solution  use only enough to dampen the unit  Towel dry the  unit after wiping it down with the cleaning solution     If a Mains fuse opens  inoperative heater   return the CTU to Medivance for service  An open fuse is  indicative of a problem that requires immediate service     3 2 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     CHAPTER 4 INSTRUCTIONS FO
17. 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  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  Verify that the unit is at least 3 4 full  If not  fill the unit     8  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     9  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     Note  If any of the check values are outside the bounds listed in  Table 4 1  calibrate the ARCTIC Sun  Temperature Management  System Model 2000 as described below              CTU Connections  Figure 5 2    Medivance   Calibration Test Unit  REF 741 00 115VAC  60Hz 4 5A  __ mer 741 00 115   46  60Hz 45A  un Been Aug 240                 Catarata USA BOLT   Naki teg KIT AT 2314   ene magin   Lverpoe  Gerten  EASE    nine    CTU Switch 1  Figure 5 3    o Pr         AA 4       CTU Switches 2 and 3  Figure 5 4    CTU S N 7001    A  10 88  B  25 55    C 34 54  D  39 99    CTU Calibration D
18. imately 40 5 CC  and  Check 4 at approximately 38  C  During this process  Patient Temperature 1  Outlet Water  Temperature 1  T1   Outlet Water Temperature 2 T2   Inlet Water Temperature  T3   Chiller  Temperature  T4   the inlet pressure  and the flow are continuously averaged monitored  Each check  point requires the following to complete successfully     e The average T2 must be within 2 0  C of the  corrected reference temperature  i e  the CTU  probe as measured by PT1      e The corrected reference temperature must momentarily cross over the desired cal  temperature   6  C  28  C   and 40 5 C  and then cross back over again  The only exception is check 4 where  the reference temperature must only drop below 38  C     e The average Inlet Pressure must be within 0 2 PSI of  7 0 PSI     e The Bypass Valve must be closed     If a check cannot be completed in 15 minutes  a message is displayed     Again  this test requires precise measurement by the patient temperature channels  Therefore  the  patient temperature checks must first be successfully completed  Further  in the measurement of  water temperature  flow is also important  Therefore  the inlet pressure check must also have been  completed as suction is the driving force in creating flow  If not   N A  is displayed at the Water check  prompt to indicate that it could not be completed     Newly calibrated temporary values are checked against the corrected average probe temperature  values obtained during the checks  
19. imer 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     11   12     13     14     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 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        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     4 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  th
20. rature High Alarm Check    12  CHAPTER 3  MAINTENANCE  ieaiaia NAG Eed NEESS e 13  3 1 Recommended Maintenance    13  3 20 e EE 13  CHAPTER A INSTRUCTIONS FOR USE    nn                                                                     AA 14  4 1 Stage 1 2  and 3  Warm up  Flow Check  Patient Temperature Calibration  Water  Temperature Calibration  and Interim Results Reporting wa wnnnawanawanasnawannan 15  4 2 Stage 4  Temperature Out Calibration us 16  4 3 Stage 5  ACCeptANCe ENEE 16  4 4 Stage 6  Water Temperature Alarm Test  16  4 5 Stage 7  Chiller Capacity Test  17  APPENDIX A SPECIFICATIONS eege ENEE EAR EENS NEESS 20    TABLE OF CONTENTS    REF 000744 01 Rev F 2    CHAPTER 1 INTRODUCTION    1 1 Use of the Calibration Test Unit  CTU  Operator s Manual   The Calibration Test Unit provides an effective and easy way of checking and calibrating  if  necessary  the ARCTIC SUN  Temperature Management System Model 2000  This Manual provides a  detailed description of the CTU  its use  construction  routine maintenance and calibration  It is  important that the CTU be properly maintained and serviced in accordance with the instructions  described in this manual  Only trained personnel should use and service this product     1 2 Customer Information and Technical Support   The CTU is intended to be used in association with the ARCTIC SUN  Temperature Management  System Model 2000 Service Manual  The Service Manual provides detailed information about the  ARCTIC SUN  Temperatur
21. rol  Module  By testing the subsystems of the CTU in sequence  operation of the Control Module can be  verified and calibrated     The CTU contains precision resistors that simulate several patient temperatures  After a warm up  period  the simulated temperatures are first applied to the Warming System 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 temporarily established  the CTU s  temperature probe is connected to the Control Module s Patient Temperature 1 input  The Control  Module then circulates water through the CTU at various temperatures  The patient temperature  channel can then be used to check and calibrate the accuracy of the internal water temperature  sensors and circuits     The fluid path in the CTU is designed to allow a specific flow  which was selected to provide this flow  rate at a given pressure  Since the Model 2000 controls the inlet pressure at a constant value  a  crosscheck of flow and pressure measurement accuracy can be obtained  The flow rate and inlet  pressure offset are checked  and the inlet pressure offset is zeroed during the initial warm up period     The CTU contains heaters that are used to slowly raise the system water temperature above its high  temperature limits in order to verify correct
22. tion Mode only if all of the following are true     e Patient Temperature 1 is between 10  C and 12  C   e Patient Temperature 2 is less than 10  C   e The reservoir level is 4 or greater   These unique conditions are required to ensure that the system is connected to the CTU  not a    patient  The operator has one minute to respond affirmatively or the Control Module returns to the  normal User Diagnostic Mode  If one of the criteria above is not met  the user is prompted to rectify it     2 5 4 Pre Warm and Flow Check    The system pre warm and flow check begins when the Test and Calibration Mode is initiated  This  process starts with an automatic 10 minute pre warm period  starting when the unit is powered on    During this time  the unit runs in Manual Mode with a 28  C water target temperature and a countdown  timer displays how many pre warm seconds remain  Additionally  the average flow rate and average  inlet pressure are displayed  Approximately 55 seconds after initiating pre warm  a bypass mode flow  check is also performed     For successful completion of pre warm to occur  the following criteria must be met     e The bypass mode flow check flow rate must be greater than 3500ml min  A timeout error is  immediately displayed if this condition is not met     e The average flow rate must be within  600ml min  of 2850ml min   9    e The inlet pressure average must be within 0 2psi of    7 0 psi   e The bypass valve must be closed     Once these conditions have been m
    
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