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        NIKI V4 Infusion Pump SERVICE MANUAL
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1.       NIKI V4    Infusion Pump    SERVICE MANUAL    0473       NIKI V4 Operator   s Manual    Table of Contents    1  INTRODUCTION       NIKI V4 Features  4  About This Manual  5  Safety Precautions  6 7  Limited warranty 8  Service Information 9   2  NIKI V4 Volumetric Infusion Pump Overview  Specifications  10 11  Front Panel     Control and Indicators 12 13  Front Panel   with Open Door  14 15  Rear Panel  16 17   3  OPERATING THE INFUSION PUMP  Operation Instructions 18  Basic Operation 19 23  Priming Function 24  Preventing Maintenance 25 26  Cleaning and maintenance 27  Alarms 28 29  Automatic Calibrations 30 31  Manual Calibration 31  Changing Default  Pressure  limit 32  Hospital Service Procedure 33 34  Failure Identification 35   4  Testing And Troubleshooting  4 1 Startup Test 36  4 2 0perational Checkout 37  4 3 Test Performing 38 41  4 4 Testing Procedures 42 49  4 5 Corrective Actions     Disassemble and Calibration 50 53  4 6 Maintenance Flowchart 54    NIKI V4 Operator   s Manual 3    1 Introduction    This Manual Provides direction for setup and operation of the NIKI V4 Volumetric  Infusion Pump     e                NIKI V4 Features  Small  light and compact pump     Multi Programs    MACRO   Macro program Infusion Rate   1 to 999 ml hr   Volume   1 to 9999 ml     MICRO   Micro program to be used in Neonatal and Pediatric  wards  Infusion Rate  0 1 to 99 9 ml hr     Volume   0 1 to 2500 ml     Highly accurate fluid delivery     Rechargeable internal battery  
2.     Housing   NIKI V4 Operator   s Manual    Specifications    Linear peristaltic movement    Micro   0 1 to 99 9ml hr in 0 1ml increments  Macro   1 to 999ml hr in 1ml increments    Micro   0 1 to 2 500ml   Macro   1 to 9 999ml     99 59 hours     5     0 1 to 5 ml hr    Ultrasonic   0 7 bar or 10 psi Adjustable   high  normal  low    100 240 V  50 60 Hz 10w 0 3A max   Nickel Cadmium 7 2V  0 9Ah    16 hours    Automatic when connected to an AC power source   12 hours     Bad System   Low  amp  End Battery   Push Run   Air   Fill Set   Bad set   High Pressure  HI PRES   down occlusion   Door Open   End of Program  FIN    Loc    138 x 138 x 72mm   5 4    x 5 4    x 2 8     Ix w xh      Attention  Consult accompanying documents   Type CF Equipment   Degree of protection against electrical shock     Protected against splashing water   Degree of protection against liquid ingress     ABS  with fire retarded   10    Electrical Safety    Memory Retention    Electrical Safety    Weight    NIKI V4 Operator   s Manual    Comply with IEC 601 1 medical equipment  and  IEC60601 2 24  Infusion pumps and controllers     All calibration and set information will be retained in  the pump memory for a minimum of 10 years     Comply with Ph60601 1  medical equipment  and  IEC60601 2 24  Infusion pumps and controllers     with UL 2601  1 and CAN CSA C22 2 No 601 1 and  MDD 93 42 EEC     1100 gr  2 5 pounds    11    Front Panel     Control and Indicators       NIKI V4 Operator   s Manual 12    Dis
3.    1 Load and prime an administration set    2 Start the pump at a rate of 125 ml hr and run for 1 minute    3 Fold and pinch the tubing just below the pump   The  HI PRSS  message for HIGH PRESSURE should appear on the display  the  audible alarm should sound and the pump should stop        WARNING  If the pump does not respond as described  remove the device  from service  Troubleshoot in accordance with section 4 4 and  repair in accordance with section4 5     Upstream Occlusion Test    The device is designed to detect an occluded administration set   Perform the following steps to ensure the performance of the upstream occlusion  sensor     Load and prime an administration set    Pinch off the tubing with a set clamp above the pump head     Set rate of 125 ml hr and start the pump      Within 3 minutes the following should occur    a  The pump stops    b  The message AIR appears on the display    c  The audible alarm is activated     RON       WARNING  If these indications do not occur  remove the device from service   Troubleshoot in accordance with section 4 4 and repair in accordance  with section 4 5     Charge Indicator Test  1  Disconnect the power cord from the AC power outlet   2  Verify that the CHARGE indicator is off  After one second    the display starts flashing constantly to indicate that the pump  is operating on battery power     D    3  Connect the power cord to the AC power outlet  Verify that the  CHARGE indicator is on  and the display has stopped fla
4.   Integrated Mounting Clamp for securing the pump to an IV pole   A B S  Anti Bolus System   Silent operation     Ultra Sonic air detection  air bubbles greater than 50 micro liters     NIKI V4 Operator   s Manual 4    About This Manual   The information in this manual is presented as follows     1  Introduction    NIKI V4 features and capabilities     2  NIKI V4 Volumetric Infusion Pump Overview    Functional description and specifications     3  Setting Up the NIKI V4 Infusion Pump    Instructions for unpacking and setting up the pump before operation     4  Operating the NIKI V4 Infusion Pump    Procedures for operating     Terms and conditions used in manual       amp    NOTE Operating procedure or condition that is essential to highlight        CAUTION A precaution that  if not followed  could result in extensive damage  to the equipment        WARNING A precaution that  if not followed  can result in personal injury or loss  of life     NIKI V4 Operator   s Manual 5    Safety Precautions       WARNING    To avoid possible personal injury or loss of life  observe the following     Note   Read and understand the entire Operation Manual before using the pump  since important precautions follow throughout the text     e Disconnect the pump from main  prior to opening the casing   Voltage present on internal components may cause severe shock or death on  contact   Only trained service personnel should open pump cover     e Before servicing pump  remove rings  watches  and ot
5.   e    Time Remain    Will automatically adjust if Total Volume is changed  during operation     e If TIME function is OFF  in technician mode  the TIME function will  not be available     ne TiO ES Plc CA USS Ore MaN OO MONS       VTBI    Displa       1     Pressing the SELECT key twice during operation causes  the displayed rate to change for 5 seconds to left    VTBI    VTBI       VOLUME INFUSED    Display     1     Pressing the SELECT key during operation causes the    displayed rate to change for 5 seconds to  the accumulated volume infused       NOTE     The VTBI and INFUSED volume will automatically reset to zero     once it reaches 9999 ml   e The volume INFUSED  can be zeroed only using the CLEAR key   e When a program was completed the VTBI will reset to the original  setting    Changing Infusion Rate During Operation    1           Press the RUN HOLD key to halt the operation of the  pump  HOLD will appear on display                 Hol        NOTE  Use the Select key to display current data   Rate   Time left  VTBI  Infused volume     Set the desired infusion rate using the arrow keys   Pressing continuously will increase the speed and steps of  changes     Press the RUN HOLD key to renew operation     NIKI V4 Operator   s Manual 21    The    Locking    Option    The NIKI V4 has a unique option  which enables the user to lock out the setting keys   so that entered parameters  or set programs cannot be changed once they are set   especially during operation    This
6.   from the front PCB and  the motor connector JP from the main PCB    8  Reassemble the pump head assembly in reverse order     eo NOTE Observe not to pinch wires and gasket between the front housing and  the pump assembly when reinstalling the pump assembly     9  The four screws S5     S7 must be tighten at a torque of 7kg   10 Perform the operation checkout procedure of section 4 2     Remove of the Pressure Sensor    Remove pump s door in accordance with section 4 5    Remove pump s assembly in accordance with section 4 5    Remove screws S8  S10  S11  Removing the pressure sensor cover   Install replacement sensor and reassemble in reverse order   Perform the operation checkout procedure of section 4 2     QU eee    Replacement of the Air Sensor  1  Replace the Air sensor   Front housing sensor  a  Separate the front and rear part of the pump in  accordance with section 4 5   b  Disconnect the Air sensor connector  JP5    c  Press on both sides of the sensor to release  connection to the front housing   a  Open S11   b  Disconnect the Air sensor wire from connector JP5   c  Pull out the sensor     Door Sensor     2  Install replacement sensor and reassemble in reverse order   3  Perform the Operation Checkout procedure of Section 4 2     Replacement of Pump Motor      Separate the front and rear housing in accordance with Section 4 5      Remove pump s door in accordance with Section 4 5      Remove pump s assembly in accordance with Section 4 5      Carefully place the 
7.   should become stable        WARNING if the device does not operate on battery power  troubleshoot in    accordance with section 4 4 and repair in accordance with section 4 5     Air Detection Test    The NIKI V4 pump is designed to detect air bubbles passing through the set  The air  bubble size detection is adjustable through the configuration option and is factory set to  50 micro liter  Section 6   If pump fails to detect air remove it from service and  troubleshoot it in accordance with section 4 4 repair and recalibrate in accordance with  section 4 5     1   2     3     Prime and load a standard administration set with one Y site above the device    Using a precise syringe  introduce an air bubble into the administration set through   the Y site above the pump  110 micro liters    Close the door and start the pump  When the intact air bubble reaches the air   sensor  the following should occur    a  Air is displayed in the Message Display    b  The audible alarm is activated    c  The pump stops    d  If the pump does not alarm  verify that the air bubble did not break up before  reaching the sensor and repeat the test     NIKI V4 Operator   s Manual 47    Pressure Detection Test    Each pump is designed to detect an occlusion downstream of the pump    If a pump fails to detect a downstream occlusion  the device should be removed from  service and repaired  Perform the following steps at room temperature to ensure proper  operation of the downstream occlusion sensor  
8.  as a  scroll down using the arrow keys  to 18  press the run hold key to confirm   pres cal      The display will show    auto cal      Load an administration set  connect a pressure gage at the end of the set  Press  run hold key to start  When the pressure gage will display 0 7 bar  press the run hold  key to hold infusion  The display will show the high pressure alarm level  and will  store the value in the memory  The pump will extrapolate from that figure the low and    normal high pressure level     NIKI V4 Operator   s Manual 30    c  Pressure setting   code 3   Set code 3  The display will show the actual pressure  Should be between 80 to 120     Press run hold key to continue  The display will show high pressure level  This  number should be between 13 to 22     Press run hold key to continue and set the high pressure absolute level  This level  should be set to 250     d  Clock setting  Set code 5  The display will show clock on off  Alternate the actual setting with the  select key  The clock off choice will eliminate the use of the time setting     d  Volume calibration setting   code 1   Set code 1  The display will show the actual calibration between 150 to 165  Those  numbers are the motor pulses requested to deliver 1 ml     Manual Calibrations    1  Press continuously on the down arrow key while switching the pump on    1 1 Press code 1 and press run key    1 2 Pump will display  cal 1  massage for Baxter set and  cal 3  massage for Abbot  set    1 3 If cali
9.  display will show the last 10 errors  each press on Run Hold  mode key will display another error  scrolling from the last to the 10      Refer to Alarm condition pg 28 for descriptions of all failures possible and instructions    on how to correct each failure   Disassemble   Reassemble and calibration procedures are located in section 4 5     NIKI V4 Operator   s Manual 35    4  Testing And Troubleshooting  4 1 Startup Test    Before attaching the NIKI V4 to a patient  run a startup test to verify that all indicators  and alarms work properly     When an alarm is activated the following will occur     1  An alarm message appears on the display   2  An audible alarm sound     3  The infusion is stopped     Pump Operation Test     1  Connect the pump to AC power  Verify that the CHARGE  Indicator is on    gt   2  Insert an administration set into the pump   3  Switch on the pump by using the ON OFF key   The pump will display ON and perform a self test  Verify that  a long beep sound is heard and that all the leds and  messages on the display are on for 2 sec    CHARGE indicator stays on constantly      4  Prime the set using the PRIME key       NOTE  Make sure the IV set is not connected to patient           5  During priming the display will show     FILL    EF        LL                         6  Verify that a    PUSH RUN    alarm appears on display after ad By CH  one minute                       M LIT                7  Press the RUN HOLD key to silence the alarm     NIK
10.  option is important in such cases as in pediatric ward  where there is a danger  that the child user will play with the pump and unknowingly change the program   Further more  in the case of the P 10 program  once locking the set programs  it will  remain in the pumps memory for the next use  even if the pump is switched off     Locking and unlocking     The NIKI lock out function disable all but the select key  while  the pump is operating  To lock out a program   At any time during operation simultaneously press the arrow up          and arrow down  The display will show    Loc    accompanied    with a short beep  RATE   To de activate or exit lock out function  simultaneously press    the arrow up and arrow down  the display will show Loc Off                 NOTE This option can only be activated while the pump is in operational state     Battery Operation    The NIKI V4 can operate on battery power  enabling operation when the patient is  being moved or during electrical power failure  When the pump runs on battery power   the CHARGE indicator is off and the display flashes     At full charge  the battery provides 16 hours of operation at an infusion rate of  125ml hr     When the pump is not in use  plug the pump   s power cord to an AC wall outlet  If  possible  to retain battery charge  If the pump is out of service for a long period   discharge  to prevent the NI CAD memory effect  and recharge the battery  periodically  at least once a month   this will insure long 
11.  the left side of the display  the word RATE will  change to TIME     The pump will automatically calculate the Total Volume     e Press SELECT key again  to set the VTBI  optional     e The pump will automatically calculate the Total Infusion  Time     NIKI V4 Operator   s Manual 19    TIME    J mU OUR       NOTE           9999    can be changed to a    0    by pressing the up arrow keys      Setting either the TIME or VTBI functions  avoids an Empty    Fluid  Container problems     9  Press the RUN HOLD key to begin infusion       NOTE  Ifthe RUN HOLD key is not pressed within one       minute  a    PUSH RUN    alarm appears on    nite PUS    Press RUN HOLD key to stop the alarm                    The display will show HOLD           PLU             10  Verify that the infusion is proceeding normally before  leaving the pump unattended          NOTE    To change any parameter during operation   first press the RUN HOLD key  HOLD  appears on display  Use the Select key to  Scroll throughout the various settings                 Holc       Set the desired rate  time or VTBI  press  e RUN HOLD key to start operation     The pump   s memory retains all parameters  even if it was turned off        TIME REMAIN    Display   During Operation   1  Pressing the SELECT key during operation causes the  displayed    RATE    to change for 5 seconds to    Time  Remains hr  min       NIKI V4 Operator   s Manual 20      NOTE       Time Remain    is stored even if the pump was switched OFF   
12. 3 8v  Connect U11 to ground  the frequency detected  should be smaller than 0 8v  Connect the same point  U11 P2  VCC the frequency  should be 40 Hz     High pressure  occlusion  Alarm Test    1 Occlude the administration set  Press the RUN HOLD key to start operation     Hi  Pre    2  After few seconds HI PRESSURE alarm will activate                                               3  Press RUN HOLD key to silence the alarm                          RATE  7         4  HOLD appears on the display  IL 1  Electrical Safety Test    Test the device leakage current and ground impedance in accordance with UL 544   Leakage current should not exceed 100 microamps  Ground impedance should be  measured on the pump s door    If the device fails to meet these requirements  remove it from service  troubleshoot it in  accordance with section 6 and repair it in accordance with section 4 5     NIKI V4 Operator   s Manual 46    Battery Test    1  With a pump running  unplug the device  No change in pumping should occur     the display will start blinking within a few seconds and the Charging led is off   The battery requires changing when LO BATT is displayed   the pump will show     Low Battery    on display and about to finish on the battery capacity screen  the  audible alarm or alert is activated     2 Connect the pump to an AC outlet   1 If the device operates satisfactorily on battery power  plug the device back     Operation should continue without interruptions and the data on the display
13. I V4 Operator   s Manual 36    4 2  Operational Checkout  Introduction    The operation checkout procedure in this section determines if the device operates  properly after it has been repaired  If the device fails any part of the operation checkout   the fault must be corrected prior to placing the device in service  Pls  become familiar  with all the checkout procedures before beginning    The following test equipment is required to perform the operational checkout procedure    Administration set    Solution container  distilled sterile water  d4w  0 9  sodium chloride ect      Precision syringe    Equipment  electronic scale  oscilloscope    Maintenance Flowchart    Pg  flowchart illustrates the maintenance procedure for the device    The operational checkout should be corrected using the troubleshooting procedures  given in section 4 4  Once a problem has been isolated to a single assembly  the  assembly should be replaced in accordance with the disassembly procedure provided in  section 4 5    The device should be calibrated as described in section 4 5  After all maintenance  procedures are completed  perform the Operational Checkout in this section     Administration set placement    To avoid possibility of fluids contacting the air sensor and pump mechanism  the  solution container should be spiked and set primed before opening a pump door  The  container should also be placed low enough to permit a loop in the tubing to the side of  the device  Position the container 
14. NIKI V4 Operator   s Manual 38    Air in Line Alarm Test    1  Press on the door   s latch to open pump   s door  Insert an  administration set  which the pump has been calibrated to  i    in the pump   s tubing guide         press here    2  Close the door  Press on the door recessions until a click is 1  heard              3  Set the infusion rate to 500ml hr  Use the arrows key                4  Press the RUN HOLD key to start operation   Turn the drip chamber  up side down  to allow 5 mm of          5  AIR alarm will activate as soon as the air bubble enter the    air to enter into the administration set   set segment located behind the pumping door    Fr                7  Press the RUN HOLD key to turn the alarm off           8  HOLD appears on the display   1   x LU  x                NIKI V4 Operator   s Manual 39    Door Open Alarm Test    1  Insert primed administration set into the pump     2  Press the RUN HOLD key to start operation     4  Close the door                 Howe    5  HOLD appears on the display              NIKI V4 Operator   s Manual 40    High Pressure  Occlusion  Alarm Test     1  Occlude the administration set  Press the RUN HOLD key to  start operation at a rate of 200 ml hr           2  After 10 seconds HI PRESSURE alarm will activate  oe   at a rate of 60 ml hr the high pressure alarm will occur after H                            60 sec  at a rate of 1 ml hr after 13 min                  3  Press RUN HOLD key to silence the alarm           4  H
15. OLD appears on the display     Hod                we NOTE The pressure threshold can be changed to suit the ward need   see  Changing the current default    Pressure    Limit to another on page 32      NIKI V4 Operator   s Manual 41    4 4 Testing Procedures    The following list of preventing maintenance for the device  which should be performed  at the intervals shown        Function Test       Pressure sensor Insert a primed set into the pump  Occlude the set  At 0 7 bar the high  pressure alarm will be activated  in case the high pressure alarm level  was set to high    0 5 bar correspond to normal setting and 0 3 bar to low    The default pressure setting is 20  this number is automatically    registered in the pump   s memory        Pressure calibration Auto pressure calibration can be performed in the following way   Switch pump on while the arrow down key is continuously pressed   The display will show    code     scroll down using the arrow key to 8888   Press run hold key to confirm    The display will show    auto cal       Load a NIKI V4 primed administration set into the pump    Connect a pressure gage at the end of the administration set    Once the pressure gage shows a pressure of 0 7 bar press the  run hold key  The display will show the pressure calibration and will  automatically register that value in the pump memory    The pressure setting  as all other settings  is registered indefinitely in    the pump   s memory  until changed by the user        Pressu
16. acing entire CCA unless circumstances warrant component repair  Use only the  replacement parts list in Section 10     Pls  read all steps in the procedure before beginning  The procedures are given in order  of disassembly  Disassembly the device only as far as required to complete repair  All  fastening components such as screws  washers and nuts used in the device are metric   Make sure to use metric tools and replace only with metric components     NIKI V4 Operator   s Manual 50       4 Caution  The device is sensitive to electrostatic discharge damage  ESD      Always wear a grounded wrist strap when performing maintenance  on the device to prevent damage to components      amp  Warning  Always make sure the device is unplugged and that the pumpis    turned OFF before disassembling  Failure to do so can result in  personal injury and   or damage to the device     Separation of Front and Rear Housing    1     Turn the device OFF and place it face down on an antistatic mat or work surface   Be careful not to lay the device face down on components  such as screws   which could damage the front panel       Remove the 4 mounting screws which secure the rear housing to the front    housing       Stand the device and separate the front and rear housing  like opening a book      While the device is open  disconnect connector JP1 and unscrew ground  connection on the pumping block  for full separation of the front and rear housing   Now the front and rear housing completely separ
17. as Air in line  Infusion is   Airis presentin   Disconnect  ed x stopped  administration administration  K M set  set from patient   E Release air  bubble from    administration  set using prime                                                                         key   PA Door is open    Infusionis   The door ofthe   Close pump door    d stopped  pump was not and restart  m    us closed prior to operation   operation  or  in APeEn was accidentally  opened  The pump is Set infusion  te     ae priming the parameters and  4 administration press  set  RUN HOLD to                restart infusion        NIKI V4 Operator   s Manual 28             La                EL          Message  displayed  showing   15  minutes left of  battery  operation     Internal battery  voltage less than  5 7V     Reconnect pump  to AC power   Recharge  battery                                                              F LL                SEE                      has detected  an  Unprimed set     Displays when   Infusion is   Battery is Reconnect pump  No battery runs stopped  depleted  to AC power   x out  Recharge   battery    Mechanical or   Infusion is Switch the   electrical stopped  pump off and   problem  CALL FOR  SERVICE    The pump eUnprimed set Prime the set                                                 LUL                      The pump Using non  Use the set the    has calibrated pump was  detected an wrong set calibrated to   unsuitable  RATE  LE set   Pump is in Press  RATE lock mo
18. ast rate setting                    5  Press the RUN HOLD key to start operation     G     amp  NOTE  The pump will prime 5 ml instead of 16 ml in case the set is partially  Primed     NIKI V4 Operator   s Manual 24    Preventing Maintenance    This following table has a list of problems and corrections to aid to the diagnosis of    possible pump malfunctions  The table contains recommended remedies to correct    malfunctions     Review this list whenever a condition exists that does not appear to be normal     Perform the specified checks and corrections  If the problem cannot be corrected    remove the pump from service  Troubleshoot it in accordance to section 4 4 and repair it    in accordance with section 4 5     Troubleshooting Guide       Function    Test    Remedy       The charging led plug  does not illuminate when  the grounded pump is  connected to AC     Check the tightness of power  Plug into the AC outlet  Check fuse    Press the power firmly  into the AC outlet    Replace if necessary       The battery indication  appears while the device    is plugged to AC battery     Check the power fuses    Replace the fuses       Battery below 7 2V    Check the AC outlet for proper    voltage    Check the device for continuity    If the voltage is 5 vac   connect the pump to a  correct supply voltage   Connect the power    terminals to an AC outlet          Air alarm       Check the position and the  seating of the tubing  Correct  any pinched or chinked tubing     Check 
19. ated    Reassemble the housing in the following order    Reconnect connectors JP1    Plug power cord into an AC outlet and check that the Charging Led is lit  If not  check for proper connection of connector JP1 or AC cable    Switch pump ON and check that the self test is performed correctly    Make sure the front and rear housing surfaces are flush before tightening   Replace 4 mounting screws  Fig 2  and tighten them to 9 kg cm  8 in Ibs  with a  toque screwdriver     Replacement of Pump s Door    QU OOS    Remove the pump s door label  NIKI V4     Volumetric Infusion Pump    Open the security screws    Open the door completely    With a thin screwdriver  push the 2 pins to the center    Reassemble the pump s door in reverse order     Replacement of Pump Assembly    1   2     Remove the pump s door cover  NIKI V4     Volumetric Infusion Pump    Remove the safety screws  S11 and S12  in the middle of the door while the door  is closed        NOTE Do not open the door when  11 or S12 are half screwed as since the    front housing may be damaged     Open the pump door and remove the two shafts P1 and P2 which are connecting  the door to the pump assembly  To remove the shafts use a thin screwdriver   Remove flow direction label    Remove S4  S5  S6  S7  Those 4 screws connect the pump assembly to the front  part of the pump     NIKI V4 Operator   s Manual 51    6  Press down the  ears  of the pump assembly to disconnect    7  Disconnect the motor sensor connector  JP1 and JP4
20. battery life      Important  Upon receipt  or following long periods of storage  it is necessary to wait  5 minutes after the pump been connected to the power supply before  operating on AC power     NIKI V4 Operator   s Manual 22    There are two battery alarm conditions     e Approximately 15 minutes before the battery runs out  a  beep sounds every 15 seconds and a signal LOW  BATTERY message appears on the display     e Ifthe battery runs out  END BATTERY appears on the  display  The pump stops operating        Caution  Leaving the battery in a discharged state for a long period of time    may damage the battery           Lo                      beet                   End                   HEE                Whenever possible  operate the pump on AC power  This preserves battery power    supply for when it is needed     Replace the battery once every 4 years     NIKI V4 Operator   s Manual 23          Priming Function    Priming Function is used   1  Before starting a program     2  After air in line alarm  Disconnect IV tubing from patient  press    PRIME    key to  push air bubbles through     Priming Function Operation        1  Switch On the pump using ON OFF key     After a short self test the pump will display ON followed by  the last rate setting       NOTE  Make sure the IV set is not connected to patient     2  Press Prime           3  The display will show FILL                          4  Once the priming is completed  the display will change  from FILL to the l
21. bration is not suitable for the set you are working with change setting    1 3 1 Turn the pump off and press continuously on the down arrow key while switching  the pump on again    1 3 2 Set code 6 and press run key  Change set setting and turn the pump off    2  Turn the pump on  Set the pump to infuse at rate 200 ml hr  VTBI 30 ml  Infuse  into a measuring cup    3  Scale the VI    4  If different than 30  45   change calibration as follows    4 1 Press continuously on the down arrow key while switching the pump on    4 2 Setcode 1    4 3 Pump will display  cal  message press run key    4 4 Pump will display a number     change according to the differences in volume  if  volume was more than VTBI  set to lower number and if the volume was lower  set to higher number     4 5 Repeat steps 2 4 until VI will be 30 ml   5     NIKI V4 Operator   s Manual 31    Changing the current default    Pressure    Limit to another       Press SELECT key continuously        Switch on the pump by using the ON OFF key   Press the RUN HOLD key  PRES shows on display for one       second  thereafter the current pressure will appear  ane HER                   By pressing the SELECT key scroll through  and choose the  desired limit        NOTE The following pressure parameters can be set           Low  0 3bar   5 psi  Ra a                Normal   0 5 bar   7 psi  Har                         High  0 7 bar   10 psi   H i                NOTE The selected pressure setting will remain in the pump   s 
22. d behind the  pump s door        High pressure    Load an administration set into the pump  Connect a pressure  gage at the end of the administration set  start a program  rate   50ml hr VTBI 20ml   Check that the Hi pressure alarm is  activated once the measured pressure amount becomes 0 7 bar   When performing the above mentioned test set the Hi pressure  alarm level high           Fill   Bad Set       Load an administration set  without the NIKI Valve  The pump  will alarm fill set after 30 sec  or bad set when 15 ml are  completed        NIKI V4 Operator   s Manual 44       Testing Procedures  Power supply test    Prepare the pump for operation according to operation instructions  pg       Separate front and rear housing according to Section 4 5  pg 52    Set a program of 200 ml hr and VTBI 10ml    Use an oscilloscope and a digital testing device  connect the ground of the oscilloscope  to the ground of the pump  Connect the oscilloscope probe to U12 P16  Check if the  voltage is constant at a level between 4 9 to 5 1v  The maximal allowed ripple should be  less than 50mV     Motor Test    Prepare the pump for operation according to operation instructions pg    Separate front and rear housing according to Section 4 5  pg 52    Set a program of 8999 ml hr and VTBI 50 ml    Use an oscilloscope and an analog testing device  connect the ground of the  oscilloscope to the ground of the pump  Connect the oscilloscope probe to U12 P20   Check if the zero level detected while mot
23. de  simultaneously    the two arrows        NIKI V4 Operator   s Manual    29       Automatic Calibrations    The NIKI V4 Volumetric Infusion Pump has many functions which allow the biomedical  department to specify the device to every department  The access to the functions are  not disclosed to the user manual  and are limited to the biomedical engineers as they  were trained to use and to decide which modes are suitable for each hospital    department     a  Automatic calibration mode  auto cal    code 8888   Press continuously on the arrow down key while switching the pump on  A continues    beep will sound  Hold pressed the arrow key until the continues beep stops  about 10  sec   in the mean time the display will show the software version  As the beep sound  stops the message on the display will change to code  Using the arrow keys scroll  down to 8888  Press run hold key to confirm  The display will show    auto cal    Load an  administration set  as described on pg 37  Use a bag with desalinates water  Prepare  a container to infuse about 20ml  Press the run hold key to start infusion  The display  will show continuously the quantity infused    When 20ml are completed the pump will alarm and display    20 00     Press the run hold  key to stop the alarm  Use a scale to weight the contents of the container    The pump   s display will show 20 00  set the actual volume delivered using the arrow  keys     b  Automatic pressure calibration  auto pres    code 8888     Same
24. distal end of the administration set in a container or a sink to dispose to  pump solution     Self Test    Turn on the pump using the on off key  Check that the device performs the following self  test    e The AC icon appears on the front panel    e Check that all leds of the display and the barleds illuminate    e The pump should perform a beep during self test and display    on     e Test the occlusion alarm  down occlusion  on 7 PSI on high pressure option    e Test the air sensor with an air bubble greater than 50 micro liter     Infusion Test      Set a flow rate of 100 ml hr  using the arrow keys     Press the select key to continue and set VTBI  volume to be infused  of 10 ml     Open the roller clamp     Press the select key to display the volume already infused     Press the run hold key to start infusion   If the pump stops with an alarm  refer to section 3 pg  28 problem checklist  Let the  pump continue to run and proceed to the next step   To reset the volume previously infused use the clear key  To read the total volume  infused  during pump s operation  and review the infusion settings press the select key   To step the infusion press the run hold key   To restart the program  press the run hold key again     When the pump has delivered the selected volume  an audible alarm is activated  while the display will show    fin       open vein        To stop an alarm  press the run hold key  Check that the pump is infusing the KVO  rate  and displays open vein     
25. ess for  a particular purpose  Purchaser expressly agrees that the remedies granted to it  under this limited warranty are purchaser s sole and exclusive remedies with respect  to any claim of purchaser arising under this Limited Warranty     Managing Director    NIKI V4 Operator   s Manual 8    Service Information    While under warranty  Service agreement   optional  or lease agreement  the instrument  must not be opened by unauthorized personnel    Contact your local distributor    Shipping costs for all units returned for service or warranty shall be paid by the  customer  The unit must be packed in its original container or in another container that  will provide adequate protection during shipment  To assure prompt return  the  customer service department must be notified before shipping any unit for repair  When  calling product service  pls  be prepared to provide code number and serial number of  the unit  A service request number will be issued should accompany all communications  A brief written description of the malfunction should be attached to the instrument when  it is returned for service     NIKI V4 Operator   s Manual 9    2  NIKI V4 Volumetric Infusion Pump Overview    Pumping Mechanism     Flow Rate     Total Infusible Volume     Total Time Setting  Accuracy    KVO rate    Air Sensor   Maximum Pressure   Power Supply   Battery     Battery Operation at 125 ml hr     Battery Charging     Alarms     Dimensions     Symbol i     Classification    IPX4  CLASS 1
26. her jewelry that may  cause a shock   burn hazard     e To prevent fire hazard  replace blown fuses only with fuses of same type and  rating   see fuse values on the rear Pcb close to the fuses housing       e The Equipment is not suitable for use in the presence of flammable  anesthetic mixture with air or with oxygen or nitrous oxide     e Watch your fingers   nails when opening the pump   s door     To avoid possible injury to patient  observe the following     e Make sure pump is attached securely to IV pole     e Ifthe pump was dropped  send the pump back to be inspected by qualified  service personnel     e Before operation  verify that administration set tubing is not kinked or  occluded      amp  NOTE  The maximum volume that may be infused under SINGLE FAULT  CONDITION is 0 1 ml     NIKI V4 Operator   s Manual 6    Safety Precautions  The pump Power cord should be connected to a grounded AC outlet Furnishing        WARNING Any adjustments  maintenance or repair of the uncovered pump  under voltage  should be avoided  If necessary  these repairs should  be carried out be skilled technicians who are aware of the hazards  involved     The should be operated within a temperature range of 15  C  59  F  to  45  C  113  F         WARNING Do not operate pump near equipment that emits high energy radio  frequencies  such as electro surgical cauterizing equipment and  cellular telephones  False alarm signals may occur      amp  NOTE  Read and understand the entire Operation Ma
27. ified  trained  service personnel  In the event that a pump is found to be defective during the  warranty period  the purchaser shall notify CME or its designated representative  within thirty  30  days after such defect is discovered     The defective pump should be sent immediately to CME or its designated  representative for inspection  repair or replacement  Shipping costs are the  purchaser s responsibility     Material returned to CME or its designated representative should be properly  packaged using CME shipping cartons and inserts  Inadequate packaging may result  in severe pump damage     This Limited Warranty shall not apply to defects or damage caused  wholly or in part   by negligence  spilt fluids  dropping of the pump  misuse  abuse  improper installation  or alteration by anyone other than qualified  trained personnel  or to damage resulting  from inadequate packaging in shipping the pump to CME or its designated  representative     If  after inspection  CME or its designated representative is unable to identify a  problem  CME or its designated representative reserves the right to invoice purchaser  for such inspection     This Limited Warranty is the sole and entire warranty pertaining to CME   s products  and is in lieu of and excludes all other warranties of any nature whatsoever  whether  stated  or implied or arising by operation of law  trade  usage or course of dealing   including but not limited to  warranties of merchantability and warranties of fitn
28. into the pump  Use an    oscilloscope  On JP8 P4 should be a pulse greater than 3 8v    pick to pick      Load a set with air  On JP8 P4 should be a pulse smaller than  0 8v  pick to pick      Load a stiff tube with air into the pump  Check on the testing  connector JP8 P5 pulse is smaller than 0 8v     In case that the pulse pick to pick on JP8 P5 is greater than 1v   use the potentiometer P1 to reduce amplifier     Check pulse on JP3 P5 if the current is more than 180 MV  If less  replaced sensor     Check on JP8 P4 if zero level is less than 0 8v continuously 1  msec        Motor sensors    Check  using oscilloscope  motor sensor channel 1 on JP8 P2   Rotate manually the encoder and check the sensor in position 1  and zero    Check motor sensor channel 2  same procedure as above  on  JP8 P3                 Input 5v Switch pump on  Check using an avometer the voltage on JP8  P7  The allowed values are between 4 9 to 5 1v   12V Input Check on JP8 P8 the 12v input  Values allowed are 11 5 to 12 5v        NIKI V4 Operator   s Manual 43       Testing Procedures       Function    Test       Open door detection    Check on JP8 P1 when pump s door is closed should be less  than 0 4v and more than 4 5v when the door is open        Alarms Air    Load an administration set into the pump  Locate the pump after  the injection port  Using a syringe  insert into the set an air  bubble of 10mm  check if Air alarm will be activated  once the  air bubble enters the administration set locate
29. memory until  changed again     Press the RUN HOLD key  in order to store the parameter in the pump s memory     NOTE The pump has an antibolus system  which prevent a bolus delivery  F to the patient  once a downstream occlusion is released     NIKI V4 Operator   s Manual 32    Hospital service procedure  Introduction    This section contains a table describing preventing maintenance which should be  performed on the NIKI V4 Volumetric infusion pump  The maintenance procedures  outline in this section may be performed in the hospital  by the biomedical department   An abnormal condition accurse which is not correctable by performing the following  procedures  remove the device from service and troubleshoot it in accordance with  section 4 4  or return it for service     Replacement of main power fuse    1 1 Switch the device off by pressing the on off key    1 2 Check if the AC icon is displayed    1 3 Remove the power cord from AC power outlet    1 4 Separate the front and the rear pump s housing as described on pg    1 5 Remove the fuses from the fuse socket on the rear PCB  and check using an  ohmmeter electrical continuity    1 6 If necessary  replace with a new fuse of the same value  type and voltage    1 7 Replace and tight fuses in the fuses housing     On the main PCB located a battery protecting fuse  F1   The nominal of the battery  protecting fuse is 1 2 A     Fuses   Nominal  On the rear PCB of the pump are located 2 safety fuses protecting the AC DC    converte
30. nual before using  pump since important precautions follow throughout the text     d CAUTION    To avoid possible damage to the equipment  observe the  following     e Do not immerse pump in liquids     e Clean solution spills immediately from the pump  Use a damp cloth  or sponge  A cleaning disinfectant may be used  Wipe thoroughly  with a dry cloth     e Do not clean pump with chemicals such as Xylene  Toluene   Acetone  or similar solvents  These chemicals cause damage to  plastic components and paint     e Do not use pens or any other sharp object to press keys  Torn or  punctured membranes expose keys to damage     NIKI V4 Operator   s Manual 7    Limited warranty on distribution sold products    The NIKI V4 infusion pump has been carefully manufactured from the highest quality  components     Caesarea Medical Electronics Ltd  Warrants that the pump will be free of defects in  material and workmanship for twelve  12  months from the date of purchase by the  original purchaser     CME s or its designated representative   s obligation under this Limited Warranty shall be  limited  at CME   s or its designated representative   s option  to repairing or replacing  pumps which upon examination  are found to be defective in material or workmanship   The repair or replacement of any product under this Limited Warranty shall not extend  the term of the Warranty beyond the original term set forth above     All repairs under this Limited Warranty should be undertaken only by qual
31. on  pressing on the on off key   pg  14  15  the display  pg 14    1  will show on and perform a self test  When the self test is completed the   display will show the last rate setting and the word rate will be displayed  Accept   pressing the select key  pg 13  3  or change with the arrow keys  pg 13  5   The   display will show the remaining VTBI  Press Run to start operation  The display   will show the volume infused  Press the clear key to zero infused volume or    run hold key to start operation     Note  The infusion indicator will flush while the pump is in operation     i  To change rate during operation press hold and use the arrow keys to change  desired data  Press the run hold key to resume operation     NIKI V4 Operator   s Manual 18    Basic Operation    1     Place the IV pole and the pump near the patient   Connect the pump to an AC power outlet     Verify that the administration set is set up correctly     Switch on the pump using the ON OFF key   ON will appear on the display followed by the last rate  setting     The preset program will appear on the right side of the  display     Press the ARROW keys to set the requested infusion rate     NOTE Press the arrow up key to increase the units  The  arrow down decreases the units     Press continuously the ARROW keys to set the  infusion rate quickly     Prime the set if necessary  use the PRIME key     To set the TIME and VTBI     e Press the SELECT key  then use the arrow keys to set  the TIME limit     e On
32. or is in stop position is greater than 1 msec    If the zero level is lower the torque required is too high    Connect the analog tester to pump s ground  Measure the current between the collector  and emitter of Q12 the main current should be less than 0 35 Amp     Watch Dog Test    Prepare the pump for operation according to operation instructions pg    Separate front and rear housing according to section 4 5  pg 52    Initiate motor movements when switching the pump on  the w d the processor will stop  the motor movements by activating the w d and display  bad sys       Set a program of 200 ml hr and VTBI 30ml  Use an oscilloscope to perform this test   Connect the oscilloscope s ground to the pump s ground    Connect the common line C5 and C61 to ground  The pump s motor will stop   Immediately stop its function and audible alarm will occur and the display will show  Err    Check on the same point if frequency can be detected  if not  check U1 P29 the  frequency output     NIKI V4 Operator   s Manual 45    Air Sensor Test    Prepare the pump for operation according to operation instructions pg    Separate front and rear housing according to section 4 5  pg 52    Set a program of 999 ml hr and VTBI 50 ml    Use an oscilloscope device  connect the oscilloscope s ground to the pump s ground   Set the pump to operate at a rate of 200 ml hr and VTBI of 30 ml    Connect the oscilloscope to the collector of Q20 to detect the pulse from pick to pick   The minimum level should be 
33. or replace  in accordance with pg  39    Battery Time Recharge by connecting to AC outlet for at least 8 hours   Check that the AC icon is displayed during    Power cord Replace the power cord if the pins are bent or the isolation is  damaged    Safety  CF  Check ground resistance measured on the pump   s door if it is       greater than 0 1 Ohm check tightness of grounding screws  It  should be 100 microamps or less using UL2601 specified test  methods  CF classification        NIKI V4 Operator   s Manual 26          Cleaning and Maintenance    WY WARNING  Do not steam autoclave or immerse the pump in liquid  as it may  otherwise be damaged   To avoid possible electrical shock  turn pump off and disconnect the  main power outlet before cleaning    Clean the pump using a soft cloth or sponge dampened with any of the cleaners listed   below  Follow manufacturer   s instructions for concentrated cleaners    Device that has been used should be cleaned and disinfected with an agent from the list    below  before reuse on another patient              Cleaner Manufacturer   LpH Septisol Vestal Labs   Cidex 7 Surgikos   Super Edisonite Edison Chemical Co   Clinidine Clinipad Co   Betadine Purdue Frederick          Do not clean the pump with acetone or other plastic solvents or abrasive cleaners   Dry the pump thoroughly before use  Consult the housekeeping and or the infection  control department for more information    Important  Do not touch the pressure or air sensors  only the t
34. plays selected infusion rate  total time  Display  volume to  be infused  and volume infused     Whenever the pump is operated on battery   the  display will blink on and off     The cursors indicate that the set program is  running     Pigy key  Sets a PIGY program      Single Pigy program PIGY    Auto Pigy program    Automatically primes the administration set Prime key  Unprimed set  priming volume 16 ml     Partially primed set  priming volume 5 ml     Increases   Decreases the infusion RATE  Arrow keys  TIME limit  and VTBI     Continue to press the arrow key to increase  the setting steps and speed     Starts or stops pump operation and delivery    RUN   HOLD Key  Hold may be used to silence an alarm  condition and pause priming     Lights when pump operates on AC power Charging Indicator    and battery is being charged  D    Opens and closes the pump door  Door Latch     NIKI V4 Door Label  VOLUMETRIC INFUSION PUMP    NIKI V4 Operator   s Manual 13              Fr M PRE EN    m    ili  ii w    Iig  inlis             N       2  E  ER O   e    NIKI V4 Operator   s Manual 14    Display LED display  i MACRO The pump is operating in the Macro program     SELECT key Used to scroll between rate  time  volume to be infused   and total volume infused       RUN   HOLD key Start hold the program   Setting the desired values for rate  time and vtbi   Pumping block mounting Connect the pumping block to the front housing    screw     Latch holder Holds the door closed when latch is 
35. positioned   Horizontally     Pressure sensor e Detects downstream tubing restriction and occlusion   e The alarm level can be adjusted to suit the needs  of the hospital department     Press plate Connected to the door by 3 springs       Recessed latch Push to open door     RATE The rate message indicates that the figure shown on the  display is the current rate       VTBI The volume to be infused     N       N    _      VI  Volume Infused  The accumulated infused volume  from the time the  CLEAR key was last pressed     ON OFF key Switches the pump on and off     Charge indicator Lights when pump is connected to main       PRIME key Pressing the prime key  at the data setting stage  after  door open or air alarm  will remove air from administration  set     ao         N      Ultrasonic air detector  mounted on the front housing       Tubing Guide Guide the Administration set      D  21  Located between the door and press plate        NIKI V4 Operator   s Manual 15      Possible explosion hazord if used xith  flannable anesthics Risque d explosion Ne pos     employer en presence d unesthesiques intlomubles    CAUTION  Electrical shock hozord Do not renove cover   Refer servicing Lo qualified service personne     THPUT 22 248 V  50 60 He 20W     NIKI V4 Yulunetric infusion punp    For use only vith the  NIKI FF loris 273 001 set     A Pi    SERIAL MUE  KAAAX  Honufoctured by CE P 0 8 424    XURET LE       NIKI V4 Operator   s Manual 16    Description Function    Pump handle P
36. pump assembly in a position when the motor plugs are up      Remove the connecting pin from the pulley on the motor shaft using a needle 1mm  thin      Remove the pulley from the motor s shaft      Remove screws  12  S13  S14 which connect the motor to the pump assembly      Install a new one in reverse order     aRWND      CON O    Replacement of Press Plate      Remove the pump s door in accordance with Section 4 5      Remove the two door shafts      Remove the Press Plate      Replace 3 springs to their place on the door      Install the new Press Plate inserting door shafts      Press the Press Plate a few times from the inside of the door to ensure smooth operation     O O1 BR    N      NIKI V4 Operator   s Manual 52    7  Install the pump s door in accordance to Section 4 5   8  Perform the operation checkout procedure of Section 4 2     Replacement of Battery      Turn of the device and separate rear from the front part in accordance with Section 4 5     Remove S25 battery pack holder      Remove the battery from its compartment disconnect JP      Compare Battery pack with figure 5      Install replacement battery pack and reassemble in a reverse order     O1       N      d Caution  Be careful with the polarity of the wires  Red wires     must be connected to  the red marked     battery terminal  The wires must be routed in the battery  compartment so that they run alongside the battery strap closet of the battery  terminal and pinch wires between the compartment and 
37. r   The nominal requested values of the fuses are 800mA    NIKI V4 Operator   s Manual 33    Tailoring the Pump to the Hospital Needs    Changing the current default Program to another     1  Press SELECT key continuously   2  Switch on the pump using the ON OFF key           3  Release the SELECT key once SLCT shows on display    ELLE                      Using the SELECT key  scroll through the different  programs and choose the desired program from the  following choices     5  Press the RUN HOLD key  in order to store the parameter in  the pump   s memory        NOTE The selected program will remain in the pump   s memory until changed  again   List of programs    The NIKI V4 volumetric infusion pump features 2 different  programs   Following are the specifications for each program     MACRO program   Rate  1 to 999ml hr    Total volume to be infused  1 to 9999ml  MACRO  MICRO program to be used in Neonatal and Pediatric wards  MICRO    Rate  0 1 to 99 9 ml hr in 0 1ml increments   Total volume to be infused  0 1 to 2500 ml     NIKI V4 Operator   s Manual 34    Failure Identification    Specific errors which may occur in the operation of the NIKI V4 Volumetric Infusion  Pump are represented on Section 3 pg 25 27  On the biomedical mode  The user can  display the last 10 failures which are stored in the device s memory    The failure information  displayed  can be used to determine the nature of a device  failure and to troubleshoot its cause     Go to biomedical code  The
38. re setting Enter    code    the same way as described above  Set CODE 3 press the  run hold key  the display will show the actual pressure     the number  displayed should be between 80 to 100    Press the run hold key again  the display will show the delta pressure  setting  Accept or change using the arrow keys    Press the run hold key to continue  the display will show the absolute    pressure level  should be 250         Occlusion test Insert a NIKI V4 primed set into the pump  Occlude the set   Check on JP8 P5 frequency increase by  number x16  300 HZ  in case    to frequency increase the sensor is either broken           Battery Check voltage drop on R45 using an avometer   Check battery voltage on connector JP8 P12   Test pump performance on battery at a rate of 125 ml hr for minimum    of 12 hours           NIKI V4 Operator   s Manual 42       Testing Procedures       Function    Test       Pump s housing    Display and Barleds    Check that all parts are in place  Clean with an agent listed on pg     Switch the pump on  check that all display segments and all  barleds are on during the initialization test  check that all numbers  on the display appear sequentially on all 4 seven segment  display           AC icon Connect the pump to mains  the AC icon shall appear on the  display  Disconnect the pump from mains  Check that the AC icon  disappears  When the pump is battery operated the numbers on  the display will flush    Air sensor Load a primed administration set 
39. shing     NIKI V4 Operator   s Manual 48    4 5 Corrective Actions  Disassembly and Calibration    This section of the manual includes a list of tools and test equipment required for  maintenance  procedures for removing and replacing subassemblies once the causes of  a malfunction after component or circuit board replacement    Detailed exploded views of the device are provided in Section 4 2     Tools and Test Equipment   The following tools and test equipment is required to perform the procedures contained  in this section  Since all fasteners on this device are metric  ensure that all tools used  are for metric fasteners  Tightening torque on certain screws is specified in kg cm and in  lbs for your convenience  The values in lbs are approximate     Test Equipment Tools   Digital Voltmeter Razor blade  Oscilloscope Phillips screwdriver  M3  Electronic Scale Normal screwdriver  M3  Electronic load device or a fixed 5 ohm  Allen key 2 5 mm     20W resistor with variable load  Antistatic mat  Antistatic work surface    When receiving a pump for maintaining   Check the last 10 alarms on the biomedical mode  can be accessed using code 10      NIKI V4 Operator   s Manual 49    List of Decisions    When receiving a NIKI V4 pump for service the first decision should be made either it s  a user mistake or pump malfunction    Secondly decide if the failure was caused by the pump or by the administration set   Than decide if it s a mechanical or an electronic problem  If the malfunc
40. so that accidental spillage onto the device will be  minimized  Do not stretch the set when removing it from packing or loading it into the    pump   Functional Testing    PIs  become familiar with the device operating procedures in the Operator   s Manual   The procedures in this section are designed to check the ability of the device to pump  primary and secondary infusion prior to test the effectiveness of its alarms  If pump fails  to perform as described or stops with a failure alarm  troubleshooting in accordance with  section 6 and repair it in accordance with section 4 5  before attempting to place the  device in service     NIKI V4 Operator   s Manual 37    4 3 Test Performing    1  Using a solution container and an administration set according to instructions  accompanying the set    2  Spike the solution container and fully prime the set  Remove container such that  the fluid level is a minimum of 18   65 cm  above the top of the pump handle  throughout the test    Make sure that the tubing is clean and dry before placing it in the pump  Make  sure that the tubing is placed and seated properly in the guide channel  Ensure  that there is no slack in the tubing and that it is not stretched  chinked or pinched  before closing the pump s door    3  Load the set into the pump  Close the pump s door  If excessive resistance is felt   check that the set is loaded properly through the tubing guide  Never use tools or  excessive force to close a pump s door    4  Place the 
41. that there are no obstruct    upstream or downstream tubing     Check the administration set for    correct type or code        Position the tubing  properly in the pump   Press run hold key to  resume operation   Remove obstruction    and or open roller clamp     Replace administration    set if required        NIKI V4 Operator   s Manual    25       Preventing Maintenance    Schedule  Every 12 months or as required       Check    Action       Check occlusion  sensor operation     section 4 2      Test occlusion sensor that is out of calibration accordance with    instructions on pg  If output   code 3  is less than 10 replace it        Check air sensor    Recalibrate any air sensor that is out of calibration in  accordance with section 4 5  Use P1 to adjust   If sensor cannot be adjusted replace it in accordance with    section 4 5        Batteries NI CAD 7 2V    Check backup battery pack voltage in accordance with section  4 2  If the backup battery is not within specification  replace it in    accordance with section 4 5           Display Segments       Switch pump ON  check all display segments and all barleds lit   using the arrow keys  check if all numbers are displayed    correctly        Schedule  As required or at least once a month       Check    Action       Pump Housing    Clean with an agent listed on pg  Replace any labels that are  damaged   Check that plastic housing is intact                    Press Plate If the press plate does not operate smoothly  clean 
42. the cover     Perform the operation checkout procedure of section 4 2   Replacement of PCB board    Separate front and rear housing in accordance with Section 4 5    Remove the PCB holding screws  S22  S23     Disconnect JP1 front and rear housing connector  motor sensor  JP2 motor JP5   Install a new PCB by performing this procedure in reverse order   Perform the operation checkout procedure of Section 4 2     a ONS    Replacement of PCB Transformer    1  Separate front and rear housing in accordance with Section 4 5   2  Remove connecting screws of rear PCB  31  S32    3  Replace the new PCB in a reverse order    4  Perform the operation checkout procedure of Section 4 2     NIKI V4 Operator   s Manual 53    Maintenance Flowchart    Receive with  suspected problem    Perform operation  checkout of section 4 5                    Does  Device perform  Operational checkout    Satisfactorily       Place device in  service        Troubleshoot in  accordance with  section 5    Repair in accordance    with section 6    Recalibrate in  accordance with  section 4 4       NIKI V4 Operator   s Manual 54    
43. tion is an  electronic one  check if it s in one of the sensors  air  pressure or motor   if one of the  sensors failed replace the sensor    If the main PCB failed replace it  Act according to instructions detailed in Section 4 5                    Decision Action   1 User mistake or pump malfunction  A user mistake     Re explain the operating  manual    2 Failure caused by the pump or by the Check the administration set    administration set    3 Mechanical or Electronic problem  Mechanical   Electronic  Check the sensors and replace  if necessary           Recording the configuration option setting    It is necessary to record the configuration option setting before beginning maintenance  procedures so that the device can be reconfigured properly when maintenance is  completed     d Caution  When the battery  EPROM s or a circuit card assembly  CCA  is  disconnected or replaced  or calibrations performed  all the  configuration options must be rest     Turn on the pump  Enter the biomedical mode    Record then prior to any maintenance actions    Press Run again  the display will show the total full hours    The pump was in operation  press Run again  the pump will display the last 10  alarms  Make a note of those alarms and try to define the direction of the  malfunction     N        Disassembly   Assembly    Disassembly of the NIKI V4 Volumetric Infusion Pump is limited to the mechanical  components and CCA  It is recommended that electrical problem be corrected by  repl
44. ubing may come in    contact with the sensors     Pressure   air in line sensors should not be clean  If it accidentally becomes wet     immediately dry the sensor with a lint free cloth     Periodic maintenance  every 12 months  should be initiated to assure the proper    function of the pump     Dropped or damaged pumps should not be cleaned   used and should be rechecked by    an authorized service technician     NIKI V4 Operator   s Manual 27       Alarms    An alarm notifies the operator user  visually and audibly that the condition shown on the  display has occurred and that corrective actions must be taken to continue the infusion   The following table lists possible alarm situations and solutions for each alarm and  indicator  However  this guide is for troubleshooting and may not describe every  possible situation or solution  If any problem cannot be resolved  the pump must be  referred to a qualified technician     When an alarm condition occurs  the following steps are recommended     e Read the alarm message displayed    e Press the run hold key to silence the alarm  The word    hold    will be displayed   Determine the cause of the alarm using the troubleshooting guide    e Correct the cause of the alarm using this troubleshooting guide    e Press the run hold key to restart the infusion    e Follow hospital guidelines if they are different from the above recommended     Alarm Conditions                   Alarm Description Result Possible Remedy  Cause      r _ 
45. ump carrying handle    Pole clamp handle Fixing the pump to an IV pole      Pump mounting screw Used to assemble disassemble the housing    Pole clamp Mounts the pump on the IV pole    re   Pole clamp screw Turn clockwise to secure the pump to the IV pole    Buzzer Sounds an acoustic alarm    ee  eal in  iil chino masini   ease pare er       NIKI V4 Operator   s Manual 17    3  Operating the Infusion Pump    Operating Instructions    a  Securely attached the pump to an IV pole using the pole clamp    b  Plug pump power cord into a hospital grade electrical outlet  Verify during  operation that the AC icon is displayed  see page 5  8  and the data on the  display is stable         WARNING  The pump is calibrated to a specific set  Do not use any other set  A  certified technician would be able to help you calibrate your set to the  NIKI V4 pump  Call your local representative for assistance     9    Prepare the IV solution container and prime the IV set being used according to   the instruction provided with the IV set  Make sure that the drip chamber is at   least one third full and that the set does not contain air  If necessary prime again   using the prime key    d  Hang the IV solution container    e  Open the pump s door  page 12  by pushing the door s latch   page 12  9  Open  the door completely    f  Place the tubing in the slit  in the arrow direction    g  Close the door by pressing on the 2 recesses  until door latch clicks firmly into  place    h  Switch the pump 
    
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