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English

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

Surface Disinfection

Disinfect the Arctic Sun™ Temperature Management System 

immediately following cleaning. Follow all manufacturers’ 

guidelines for the pre-saturated germicidal wipes, including 

wearing gloves and other personal protective equipment 

when dispensing and using the wipes.

Manual Disinfection:

•   Disinfection  Materials: 

Required

: Pre-saturated germicidal wipes (active 

ingredient – alcohol)

Validated

: Super Sani-Cloth Germicidal Disposable Wipe

• Disinfection
1.   Using pre-saturated germicidal wipes, disinfect all 

external surfaces of the Arctic Sun™ Temperature 

Management System.
a)   Ensure that all surfaces are dampened, including all 

seams of the device.

b)   Use as many clean towelettes as necessary to 

ensure device is completely dampened with 

disinfectant.

c)   Thoroughly wipe the following with additional 

clean towelettes – fluid delivery line, power cable, 

temperature cables, USB cable, RS232 cable.

2.   Allow the treated surfaces to remain wet for the 

manufacturer’s specified contact time. 

3.   Wipe each surface of the device with a lint-free cloth 

premoistened with sterile water.

4.  Let air dry.
5.  Reattach cables and hoses.

Visual Inspection and Return to Use

1.   After cleaning and disinfecting the device per 

the instruction provided, examine the device for 

cleanliness. If visible soil remains, repeat manual 

cleaning instructions.

2.  Inspect cables and hoses for signs of damage. 
3.  Inspect external shell for discoloration or cracking. 
4.  Inspect labels for legibility. 
5.   Do not use the device if it has failed visual inspection 

for soil after multiple cleaning attempts, or if there 

is visible damage. Contact Customer Support for 

additional recommendations.

6.   Store the device in a dry and clean environment when 

not in use.

Note:

 The device has been validated for exterior surface 

cleaning and disinfection per the instructions provided. 

Any deviation from the recommended parameters must 

be validated by the user. Interior surface of the device 

(including deep crevices) are not addressed as part of this 

cleaning and disinfection 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 contact BD Customer Support.

Inspect Connectors and Cables

Inspect the patient temperature cable(s) and power cord 

for integrity. Ensure temperature cables are properly strain 

relieved. Ensure power cord bracket is secure.

Condenser

•   A dirty chiller condenser will significantly reduce the 

cooling capacity of the Control Module. 

•   To clean the condenser, wipe the dust from the exterior 

grill using a soft cloth. Depending on the quality of your 

institution’s air, periodically remove the back cover and 

vacuum or brush the condenser fins. At a minimum the 

condenser fins should be cleaned annually. Maintenance 

activities should be performed by qualified personnel. 

Device Inspection

•   Periodically inspect the external areas of the device for 

damaged, loose or missing parts, and frayed or twisted 

power cords and cables. 

•   Discontinue using the device displaying one or more of 

the above conditions until the problem is corrected and 

has been verified to be operating correctly. 

Replenish Internal Solution

Contact Customer Service to order internal Arctic Sun 

Cleaning Solution. 

To replenish the internal Arctic Sun Cleaning Solution: 

1.  Drain the reservoir. 

•  Turn Control Module Power Off. 
•   Attach the drain line to the two drain ports on the 

back of the Control Module. Place the end of the drain 

line into a container. The water will passively drain 

into the container.

2.  Refill the reservoir. 

•  Connect the fill tube.
•   From the Hypothermia therapy screen or the 

Normothermia therapy screen, press the Fill Reservoir 

button. 

•   The Fill Reservoir screen will appear. Follow the 

directions on the screen. 

•   Add one vial of Arctic Sun™ Temperature 

Management System cleaning solution to the 

second liter of sterile water. 

•   The filling process will automatically stop when the 

reservoir is full. Continue to replace the bottles of 

sterile water until the filling process stops. 

•   When the Fill Reservoir process is complete, the screen 

will close. 

Note:  

The reservoir level sensor requires a conductive fluid to 

operate properly. Filling the reservoir without using the 

Arctic Sun Cleaning Solution may result in overfilling 

the reservoir.

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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