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English

The current Service Manual can be found at www.medivance.com/manuals

Fill Reservoir

Approximately four liters of sterile water will be required to fill 

the reservoir at initial installation. Fill the reservoir with sterile 

water only. When filling the Control Module during initial 

installation or when completely empty, add one vial of Arctic 

Sun™ Temperature Management System Cleaning Solution 

to the sterile water. It is recommended to add the vial when 

filling with the second liter of sterile water. 

1.   From the Patient 

Therapy Selection

 screen, select the 

button next to either Normothermia or Hypothermia 

under the New Patient heading. Select any pad type to 

continue.

2.   From  the 

Hypothermia

 or 

Normothermia

 therapy 

screen, press the 

Fill Reservoir

 button. 

3.   The 

Fill Reservoir

 screen will appear. Follow the 

directions on the screen.

4.   The filling process will automatically stop when the 

reservoir is full. Continue to replace the bottles of sterile 

water until the filling process stops. 

5.   When  the

 Fill Reservoir

 process is complete, the screen 

will close.

6.  To stop the process early, press the 

Stop

 button.

Note

:  If the filling cycle is stopped prior to completion, 

the reservoir will not be full and may requiring 

filling after fewer patient therapies have been 

performed. 

7.  Press the 

Cancel

 button to close the screen.

Fig 1-6 Fill Reservoir Screen

Functional Verification

Certificates of Conformance for calibration, performance, and 

electrical safety tests are included with the shipment of each 

Arctic Sun™ Temperature Management System. To verify 

the system will heat and cool properly, perform the following 

functional verification procedure after initial setup and 

installation of the Control Module.

1.  Power On the Control Module.
2.   From  the

 

patient

 Therapy Selection

 screen, press 

the button next to 

Hypothermia

 to display the 

Hypothermia

 therapy screen. Select the adult pad type 

to continue. 

Fig 1-7 Manual Control Settings Screen

3.   From  the 

Hypothermia

 therapy screen, press the 

Manual Control

 button to open the 

Manual Contro

window. If the Manual Control button is not visible, 

select the Adjust button at the bottom of the screen 

and select the 

More

 button to access the therapy 

settings screen. Enable Manual Control by pressing the 

up arrow once and save your settings. Press close to 

close the settings window. 

4.   From the therapy screen, press the 

Manual Control

 

button. Use the Up and Down arrows to set the 

Manual Control water target temperature to 40°C and 

the duration to 30 minutes.

5.   Press  the 

Start

 button to initiate 

Manual Control

Allow at least 3 minutes for the system to stabilize. 

6.   Monitor the flow rate and water temperature in the 

System 

status

 

area on the

 Hypothermia

 therapy 

screen. 

7.   Verify that the flow rate reaches at least 1.5 liters/

minute. 

8.   Verify that the water temperature increases to at least 

30°C. 

9.   Set the Manual Control water target temperature to 

4°C and the duration to 30 minutes. 

10.  Monitor the flow rate and water temperature in the 

System

 status area of the 

Hypothermia

 therapy 

screen. Verify that the water temperature drops to 6°C 

or colder. 

11.   Press  the 

Stop

 button to stop 

Manual Control

12.   Press  the 

Cancel

 button to close the 

Manual Control

 

window.

13.  Before placing the device into clinical use, it is 

recommended to disable Manual Control unless 

requested by clinical users. Select the 

Adjust

 button at 

the bottom of the therapy screen and select the 

More

 

button to access the therapy settings screen. Disable 

Manual Control and save your settings to close the 

window. 

14. Power Off the Control Module.

Содержание Arctic Sun Stat

Страница 1: ...Arctic Sun Stat Temperature Management System SERVICE MANUAL...

Страница 2: ......

Страница 3: ...5 Replace Front Case Assembly Components 36 8 6 Replace the Control Panel Assembly 37 8 7 Removing Replacing Circuit Cards from Card Cage 37 8 8 Replace the Panel ESD Board 39 8 9 Replace the Connect...

Страница 4: ...en connected to an equivalent receptacle marked hospital use or hospital grade When using the Arctic Sun Temperature Management System note that all other thermal conductive systems such as water blan...

Страница 5: ...under the ArcticGel pads often especially those at higher risk of skin injury Skin injury may occur as a cumulative result of pressure time and temperature Possible skin injuries include bruising tear...

Страница 6: ...trolling of patient temperature should only be performed under the supervision of a qualified healthcare professional Setup Procedure Unpack 1 Unpack the Arctic Sun Temperature Management System Contr...

Страница 7: ...abled 16 Rewarming Hypothermia Screen Patient Pad Selection Screen Once the therapy has been selected the user will be prompted with the Pad Selection screen Select the appropriate pad type based on t...

Страница 8: ...nstallation of the Control Module 1 Power On the Control Module 2 From the patient Therapy Selection screen press the button next to Hypothermia to display the Hypothermia therapy screen Select the ad...

Страница 9: ...sists of 4 heating rods The heating element within each rod is in series with a non resettable thermal fuse which protects each rod against an over temperature condition Inlet Outlet Manifold connects...

Страница 10: ...d meters it into the Chiller Tank Cold water overflows from the Chiller Tank into the Circulation Tank The speed of the mixing pump is dependent upon the flow rate through the circulation tank and the...

Страница 11: ...0 uses whichever occurs first as indicated by system display Clean the External Surfaces After use the external surfaces of the Arctic Sun Temperature Management System may be a potential biohazard Th...

Страница 12: ...ion protocol To prevent possible discoloration do not use iodine based solutions such as Betadine on any part of the machine For questions on device cleaning and disinfection of external surfaces cont...

Страница 13: ...resent and that the rings make an intact seal with the Fluid Delivery Line System Diagnostics Select the System Access button on the Normothermia therapy or Hypothermia therapy screen to access System...

Страница 14: ...The USB data port is to be used only with a standalone USB flash drive Do not connect to another mains powered device during patient treatment Patient Data Fields Parameter Units Date MM DD YY Time H...

Страница 15: ...indicated on the display screen Calibration instructions are stored in the device and can be accessed from the calibration screens on the Advanced Setup Screen Calibration should be done only by trai...

Страница 16: ...o the local requirements From the Advanced Setup screen press the button to the right of the Date Format parameter Use the Up and Down arrows to select the date format Range MM DD YY DD MM YY DD MM YY...

Страница 17: ...n of power the device will issue alarm 45 There are two types of conditions Medium Priority Alarms and Low Priority Alarms Non Recoverable Alarms If an Alarm condition occurs that prevents proper use...

Страница 18: ...r leak or low flow Wait a minimum of 45 seconds for the air to clear the line and then check to see if the flow has increased If faulty pad found replace faulty pad 5 To check whether a valve is leaki...

Страница 19: ...hat may affect cooling Are the machine vents blocked Is the room temperature too high Is the oxygen heated Are there hot lights or heating blankets on the patient Remove any impediments Monitor water...

Страница 20: ...is not working Call BD Customer Support If the water temperature increases to the commanded temperature the water heating system is working 5 Verify Patient Control System Performance Place system bac...

Страница 21: ...e and temperature cable is secure 4 Check that the connection between the temperature cable and the Temp In 1connector is secure 5 Check the integrity of the temperature cable Flex the cable to check...

Страница 22: ...ntal conditions that may affect cooling Are the machine vents blocked Is the room temperature too high Is the oxygen heated Are there hot lights or heating blankets on the patient Remove any impedimen...

Страница 23: ...emperature the water heating system is not working Call BD Customer Support 5 Verify Patient Control System Performance Place system back into the patient control mode Monitor water temperature and pa...

Страница 24: ...em is unable to internally check the calibration of the Patient Temperature 2 channel within 1 0 C when the system is in Manual Control mode Patient Temperature 2 channel is made inactive 1 Power syst...

Страница 25: ...ority Alarm One or more of the entries into the system event log is invalid The system event log is used by clinical engineering personnel for product service This issue does not affect the performanc...

Страница 26: ...ng is activated The system is not in Manual Control mode The high water temperature limit and low water temperature limits are set correctly See VI Operation Guide Therapy Settings High Water Limit or...

Страница 27: ...ing which may or may not be visible Consider administration of additional medication for shivering control adequate for the patient weight and magnitude of shivering follow physician orders institutio...

Страница 28: ...omer Support 80 Non Recoverable System Error Medium Priority Alarm The control processor failed to detect a simulated water temperature fault 1 Turn Control Module Off Wait 30 seconds and turn Control...

Страница 29: ...he use of an esophageal temperature probe when patient target temperature control below 33 C is set Place esophageal temperature probe in patient and connect to the Temp In 1 cable on the back of the...

Страница 30: ...Make Clinical Decision If all of the above considerations have been addressed and the patient still has not reached target temperature the physician and nursing staff make a clinical decision to limi...

Страница 31: ...ypothermia Therapy Setting screen With the device at room temperature power the device on wait 5 minutes and check the Chiller temperature T4 on the Diagnostic screen This temperature should be below...

Страница 32: ...Fluid Delivery Line and place thumb over the left port Repeat the test in step 3 To confirm there are no leaks in the Fluid Delivery Line valves attach a shunt tube to any set of valves and initiate M...

Страница 33: ...moval and replacement of the component A list of spare parts and accessories is located in Appendix D In general reverse the order of removal to install a replacement component Please note any special...

Страница 34: ...edivance com manuals Fig 8 2 Control Module Front inside view AC Breaker Harness Manifold Harness Card Cage Main Harness Pump Connections Control Panel Connection Chiller Power Connection Chiller Evap...

Страница 35: ...32 Service Manual Fig 8 3 Control Module Right inside view Transmission Interface Module Connector Panel Bracket I O Manifold Chiller Pump Drain Cup Chiller Condenser Hot Gas Bypass Valve...

Страница 36: ...33 English The current Service Manual can be found at www medivance com manuals Fig 8 4 Control Module Left inside view Heater Harness Connection AC Breaker Harness Connection Chiller Fan...

Страница 37: ...rd Identification Fig 8 6 Power Supply Fig 8 7 AC PCB The following two 2 Circuit Cards are mounted on the lower bracket next to the Chiller Condenser Input Output I O Circuit Card Isolation Circuit C...

Страница 38: ...lade screwdriver 13 16 21mm wrench 9 16 14mm wrench 7 16 11mm wrench 1 16 1 5mm hex key Wire cutter small Needle nose pliers Total Drain A total drain activates the pumps to remove residual water It i...

Страница 39: ...the zip tie around the communications connector and disconnect both communications and power connections from the top of the card cage Fig 8 11 Disconnect cables from control panel step 2 Fig 8 12 Rem...

Страница 40: ...y then remove the bracket assembly with harnesses attached from the control panel 7 Grasp new Control Panel and slide into the front panel by first aligning the panel just below the screws in the hand...

Страница 41: ...ircuit Card perform a calibration see Chapter 9 Fig 8 17 Disassemble Connector Panel from Chiller Frame Fig 8 18 Suspend Connector Panel by wiring harness Fig 8 19 I O Circuit Card Connections Fig 8 2...

Страница 42: ...the new panel ESD board and secure with the four 4 phillips head screws then reattach the blue temp connector PCB cable to the back of the board 7 Reinstall the Lemo nuts for PT1 PT2 and Temp out on t...

Страница 43: ...ly to the device and connect the blue temp connector PCB cable to the isolation board Fig 8 25 Placement of AC Breaker Harness Connections Fig 8 26 Connector Panel Bracket Assembly 3 Assemble the new...

Страница 44: ...e 12 O clock position and replace the nuts to the backsides of valve 5 Connect tubes to backside of drain valve and refasten drain cup to chiller frame with the hex screws Fig 8 31 Remove tubing from...

Страница 45: ...he solenoids are installed in the correct locations see fig 8 37 Note When reinstalling the solenoids if they are not installed properly it will prevent the device from functioning properly 7 Remount...

Страница 46: ...talled with the upper right screw on the circuit card 9 Reinstall the jumper to the AC PCB and connect the two 2 lower main harness connections on the power supply board Fig 8 39 Placement of power in...

Страница 47: ...pin exposed below left and seated correctly below right 8 19 Replace Circulation Pump Tools and Supplies required Flat blade screwdriver Small flat blade screwdriver Wire cutters 1 Lift upper bracket...

Страница 48: ...he harness from J1 on the AC PCB 3 Remove the black foam covering the two 2 hex head screw securing the heater to the lower bracket Then using a 7 16 11mm nut driver remove the two 2 screws Attention...

Страница 49: ...require the removal of the Internal Components via the following steps Attention Ensure the unit is drained prior to completing any repairs in this section 1 Loosen the two 2 hose clamps that hold the...

Страница 50: ...acket 4 Carefully pull down on the chiller pump to remove it from the tank 5 Place two 2 new O rings in the slots on the chiller pump outlet as shown Ensure that the O rings sit completely inside the...

Страница 51: ...d carefully install the thermistors into the tank Tighten the thermistors finger tight plus turn ensuring washer is compressed between the tank and sensor housing Note Verify the proper locations of T...

Страница 52: ...cessful completion of a calibration check a report is displayed showing a pass or fail status of all parameters checked 9 3 Calibration Setup 1 Remove fluid delivery line by flipping latch from right...

Страница 53: ...tor to arrange for disposal Parameter Specification Therapy Modes Normothermia Control Patient Rewarming Hypothermia Cooling Rewarming Heater Maximum Power 814 Watts Circulating Fluid Sterile Water wi...

Страница 54: ...ce no 5 1 7 Medical Devices Symbols to be used with medical device labels labelling and information to be supplied Serial number Indicates the manufacturer s serial number so that a specific medical d...

Страница 55: ...ectrical Equipment in Medical Practice Draining emptying To indicate the emptying of any vessel or container of liquid or produce for example draining of oil tanks draining ink reservoirs or emptying...

Страница 56: ...e the content of the package is fragile and that the package must be handled with care IEC TR 60878 Reference no 0626 Graphical Symbols for Electrical Equipment in Medical Practice Keep away from rain...

Страница 57: ...used when filling the ARCTIC SUN Stat Temperature management system Control Module N A N A N A Identifies Patient Temperature 1 the patient temperature probe input for monitoring and control N A N A N...

Страница 58: ...should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Arctic Sun Temperature Management System uses RF...

Страница 59: ...00 iDEN 820 CMDA 850 LTE band 5 Pulse mod 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMts Pulse mod 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLA...

Страница 60: ...SD Board 404121 00 Connector Panel Assembly 404122 00 Control Panel Strap 404123 00 Fluid Drain Door Assembly 404124 00 Bracket Power Cord RoHS 404130 00 RIM Back Panel 404131 00 PCB Connector Cable 4...

Страница 61: ...58 Temperature In Cables Temperature Out Cables Service Manual Appendix E Temperature Cables...

Страница 62: ...am 3 Place top support on top of the device with the foam side down 4 Add top shelf to the top of the support and place any accessories being shipped with the unit into the shelf 5 Install sleeve over...

Страница 63: ...ss or failure of the software install If software install fails at any point a red X will appear and process will not reach 100 5 Screen will go blank after completion wait for a mimum of 1 minute the...

Страница 64: ...LT FREE AND OCCASIONAL PERIODS OF DOWNTIME OCCUR BARD DOES NOT GUARANTEE THE USE OF THE EQUIPMENT AND ITS CONNECTIVITY FEATURES WILL BE UNINTERRUPTED TIMELY SECURE OR ERROR FREE OR THAT CONTENT LOSS W...

Страница 65: ...l Sequence Number 1 2 3 4 5 Initialized at power up 3 Patient Temperature 1 C 0 if probe not connected 4 Patient Temperature 2 C 0 if probe not connected 5 Patient Target Temperature in Auto Mode C re...

Страница 66: ...63...

Страница 67: ...p 720 880 5400 Fax lou customerservice bd com PK2800349 02 2021 2021 BD BD and the BD Logo are trademarks of Becton Dickinson and Company Bard ArcticGel Arctic Sun Medivance and Simply Advanced are tr...

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