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English

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

Chapter 1 – Getting Started

Introduction

 

The Arctic Sun™ Temperature Management System is a 

thermoregulatory device that monitors and controls patient 

temperature within a range of 32°C to 38.5°C (89.6°F to 

101.3°F).
A patient temperature probe connected to the Control 

Module provides patient temperature feedback to an internal 

control algorithm which automatically increases or decreases 

the circulating water temperature to achieve a pre-set patient 

target temperature determined by the clinician.
The Arctic Sun™ Temperature Management System pulls 

temperature-controlled water ranging between 4°C and 

40°C (39.2°F and 104°F) through the ArcticGel™ pads. This 

results in heat exchange between the water and the patient.
The Arctic Sun™ Temperature Management System Control 

Module is a Class I mobile device (Type BF, IPX0 and Mode 

of Operation – Continuous) per classification scheme of IEC 

60601-1.
The Arctic Sun™ Temperature Management System Control 

Module meets both the electromagnetic interference 

and susceptibility requirements of IEC 60601-1, and is 

compatible with other equipment that also conforms to 

that standard. There is no known failure mode in the Arctic 

Sun™ Temperature Management System Control Module 

associated with electromagnetic interference from other 

devices. See Appendix C for the full declaration regarding 

electromagnetic compatibility.
The Arctic Sun™ Temperature Management System

 

was 

designed with ease of service in mind and incorporates several 

features that will assist clinical engineers in maintaining its 

performance. These features include negative pressure flow 

that eliminates water leaks, real-time air leak detection, and 

performance monitoring. It also includes access to alarm logs 

and past system case data, real-time diagnostic information, 

simplified calibration and maintenance, and modular 

construction allowing for simple repair if required. 

Indications for Use

The Arctic Sun™ Temperature Management System

 

is a 

thermal regulating system, indicated for monitoring and 

controlling patient temperature in adult and pediatric 

patients of all ages. 

Warnings and Cautions

         WARNINGS

•  Do not use the Arctic Sun™ Temperature Management 

System in the presence of flammable agents because 

an explosion and/or fire may result. 

•  Do not use high frequency surgical instruments 

or endocardial catheters while the Arctic Sun™ 

Temperature Management System is in use. 

•  There is a risk of electrical shock and hazardous moving 

parts. There are no user serviceable parts inside. Do not 

remove covers. Refer servicing to qualified personnel. 

•  Power cord has a hospital grade plug. Grounding 

reliability can only be achieved when connected to an 

equivalent receptacle marked “hospital use” or “hospital 

grade.”

•  When using the Arctic Sun™ Temperature Management 

System, note that all other thermal conductive 

systems, such as water blankets, water gels, and 

patient coverings in use while warming, cooling, or not 

delivering therapy with the Arctic Sun™ Temperature 

Management System may actually alter or interfere 

with patient temperature control. 

•  Do not place ArcticGel™ pads over transdermal 

medication patches as temperature can impact drug 

delivery rate, resulting in possible harm to the patient.

•  The Arctic Sun™ Temperature Management System 

is not intended for use in the operating room 

environment.

•  Protection of mechanical equipment against the effects 

of the discharge of cardiac defibrillators is dependent 

upon the use of appropriate cables. Use of temperature 

cables listed in the System Components section of the 

Operator’s Manual is recommended.

•  Portable RF communications equipment (including 

peripherals such as antenna cables and external 

antennas) should be used no closer than 30 cm (12 

inches) to any part of the Arctic Sun™ Temperature 

Management System, including cables specified by 

the manufacturer. Otherwise, degradation of the 

performance of this equipment could result.  

    CAUTIONS

•  This product is to be used by or under the supervision of 

trained, qualified medical personnel. 

•  Federal law (USA) restricts this device to sale, by or on 

the order of a physician. 

•  Use only sterile water. The use of other fluids will 

damage the Arctic Sun™ Temperature Management 

System. 

•  When moving the Arctic Sun™ Temperature 

Management System always use the handle to lift the 

controller over an obstacle to avoid over balancing. 

•  The patient’s bed surface should be located between 30 

and 60 inches (75 cm and 150 cm) above the floor to 

ensure proper flow and minimize risk of leaks.

•  The clinician and/or operator is responsible to determine 

the appropriateness of custom parameters. When the 

system is Powered Off, all changes to parameters will 

revert to the default unless the new settings have been 

saved as new defaults in the Advanced Setup screen. For 

small patients (≤30 kg) it is recommended to use the 

following settings: Water Temperature High Limit ≤40°C 

(104°F); Water Temperature Low Limit ≥10°C (50°F); 

Control Strategy = 2. It is recommended to use the 

Patient Temperature High and Patient Temperature Low 

alarm settings. 

•  Manual Control is not recommended for patient 

temperature management. The operator is advised to 

use the automatic therapy modes (e.g. Control Patient, 

Cooling, Rewarming) for automatic patient temperature 

monitoring and control. 

•  The Arctic Sun™ Temperature Management System will 

monitor and control patient core temperature based 

on the temperature probe attached to the system. 

The clinician is responsible for correctly placing the 

temperature probe and verifying the accuracy and 

placement of the patient probe at the start of the 

procedure. 

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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