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

Appendix H-  Warranty

BARD

LIMITED WARRANTY 

ON ARCTIC SUN

 STAT TEMPERATURE MANAGEMENT SYSTEM

Limited Warranty 

Bard Medical Division, C. R. Bard, Inc. (“Bard”) warrants to the original customer that each Arctic Sun

TM

 Control Module (“Equipment”) and ArcticGel

®

 Pad 

(“Disposable”) will be free of defects in workmanship and materials for the period set forth in the labeling and if no such period is set forth, then one year from the 

date of purchase. If the Equipment or a Disposable proves to be so defective, such Equipment or Disposable may be repaired, replaced, refunded or credited, at 

Bard’s option. A comprehensive post warranty service plan for Equipment is available for purchase. The warranty covers all parts and labor associated with defects 

in material and workmanship of the Equipment and Disposable. Bard will, at its discretion, determine if the Equipment or a Disposable is to be repaired on site, or 

at the Bard service center. If Equipment or a Disposable is to be returned for service, Bard will supply packaging materials and pay for ground shipping. However, 

it is the customer’s responsibility to prepare and package the Equipment or Disposable for shipment at its own cost. Any expedited shipment request will be at the 

customer’s expense. Any unauthorized Equipment or Disposable repair performed during the warranty period will void the warranty. All returns must be authorized 

in advance by Bard. The liability of Bard under this product warranty does not extend to any abuse, accidental damage, misuse, improper storage, alteration, further 

manufacture, packaging or processing, accidental damage or damage from misuse of Equipment, damage caused by using tap water rather than distilled water, 

routine maintenance, recalibration, or its repair by any person or entity not authorized by a Bard representative.

Disclaimers

I. 

THE LIMITED WARRANTY PROVIDED ABOVE IS THE ONLY WARRANTY PROVIDED BY BARD AND IS IN LIEU OF ANY OTHER WARRANTIES, WHETHER 

EXPRESS, IMPLIED, OR STATUTORY, INCLUDING title, non-infringement, non-interference, interoperability, quality or condition, accuracy, completeness, 

merchantability, fitness for a particular purpose, or the absence of any defects, whether latent or patent.
II. 

CUSTOMER IS RESPONSIBLE FOR THE PERFORMANCE OF ITS RESEARCH AND THE CARE OF ITS PATIENTS, AND DETERMINING THE APPROPRIATENESS 

OF THE EQUIPMENT AND DISPOSABLES FOR ITS USE; CUSTOMER ACKNOWLEDGES THAT Bard is not responsible for the delivery of medical care or medical services 

to customer’s patients or any other person. The Equipment and Disposables are a tool to be used by customer but do not replace professional skill or judgment. By 

providing the Equipment and Disposables to customer, neither Bard nor any employee of Bard is engaged in the practice of medicine. Customer is responsible for 

verifying the accuracy, completeness, and pertinence of any medical, patient, legal or other results, data or information entered in, received by, processed by, stored 

in, transmitted by, produced by, displayed by, or used in connection with the Equipment and Disposables. Customer assumes all risks and liabilities associated with 

the use of such information, whether such information is used alone or in combination with other information. Bard is not responsible for the performance, support, 

or any other aspect of customer’s technology environment.
III. 

CUSTOMER ACKNOWLEDGES THAT COMPUTER AND TELECOMMUNICATIONS SYSTEMS ARE NOT FAULT-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 WON’T OCCUR, NOR DOES BARD GUARANTEE ANY CONNECTION TO OR TRANSMISSION FROM THE 

CUSTOMER TECHNOLOGY ENVIRONMENT.
IV. 

Exclusions.

 The foregoing warranties will not apply to failure of any Equipment or Disposable caused by (i) customer’s abuse, neglect or misuse or 

resulting from any failure to comply with the customer’s responsibilities; (ii) malfunction or failure of any element of customer’s technology environment or use other 

than as expressly authorized by Bard; (iv) customer’s failure to maintain the physical environment for the Equipment (including normal maintenance) specified in 

the relevant documentation provided by Bard; (v) malicious software not introduced by Bard; or (vi) customer’s failure to permit installation of any software updates 

or upgrades.
THE LIABILITY AND REMEDY STATED IN THIS LIMITED WARRANTY WILL BE THE SOLE LIABILITY OF BARD AND REMEDY AVAILABLE TO CUSTOMER WHETHER 

IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND BARD WILL NOT BE LIABLE TO CUSTOMER FOR ANY SPECIAL, INDIRECT, INCIDENTAL 

OR CONSEQUENTIAL DAMAGES ARISING OUT OF HANDLING OR USE OF BARD EQUIPMENT OR DISPOSABLES EVEN IF BARD HAS BEEN ADVISED OF THE 

POSSIBILITY OR LIKELIHOOD OF SUCH DAMAGES. IN NO EVENT WILL BARD’S LIABILITY UNDER THIS WARRANTY EXCEED THE PURCHASE PRICE PAID TO BARD 

BY CUSTOMER FOR SUCH EQUIPMENT AND DISPOSABLE.

Terms of Service

If Equipment availability is critical for patient treatment, it is the customer’s responsibility to purchase back-up Equipment. Although Bard will attempt to promptly 

repair Equipment under warranty, the timeliness of repair is not guaranteed.
The customer is responsible for maintaining the Equipment according to the schedules and instructions in the documentation supplied with each system. Bard 

provides remote Technical Support from 8:00AM to 5:00PM Mountain Time and 24/7 emergency phone support. Contact customer Service for all service related 

requests. A detailed description of the problem or service required, the unit serial number, and contact information will be required to assist in providing efficient 

service of the unit. The customer must provide personnel to assist Technical Support with troubleshooting.

Loaned Equipment

If Equipment under warranty is returned for service, subject to availability, loaned Equipment may be available to the customer at no charge upon request for the 

duration of the service. The customer is responsible for setting up the loaned Equipment and to prepare and package the Equipment for return shipment according 

to the documentation. The customer is also responsible for the care and maintenance of the loaned Equipment and all accessories while the Equipment is in their 

possession. Any loss or damage will be the sole responsibility of the customer. Loaned Equipment must be returned within 7 days upon return of the repaired 

Equipment or rental charges will be applied at a rate of $50 per day. Loaned equipment will be shipped ground at Bard’s expense.  Any expedited shipment request 

will be at the customer’s expense.

Non-Warranty Service

Parts and service are available for a fee through customer Service for Equipment no longer under warranty. If requested, Bard can provide an estimate of the cost 

of factory repair. Bard will require a Purchase Order from the customer in order to initiate the repair service. If it is later determined the Equipment requires repair 

which exceeds the original estimate, Bard will contact the customer for authorization prior to proceeding with the repair.  

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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